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Failure Mode and Effects Analysis based on FMEA 4 th Edition
Failure Mode and Effects Analysis based on FMEA 4th Edition Mark A. Morris ASQ Automotive Division Webinar November 30, 2011 [email protected] www.MandMconsulting.com Purpose of this Course • Enable participants to understand the importance of FMEA in achieving robust capable designs and processes. • Teach participants how to improve the efficiency and effectiveness of their FMEA efforts. • Get the right people involved in the process of FMEA, and get results. • Have Fun Learning!!! Learning Objectives Participants will be able to: Explain the purpose, benefits and objectives of FMEA. Select cross-functional teams to develop FMEAs. Develop and complete a FMEA. Review, critique, and update existing FMEAs. Manage FMEA follow-up and verification activities. Develop FMEAs in alignment with AIAG FMEA reference manuals. Changes in the FMEA Manual (4th Ed.) • • • • • • • • Improved format, easier to read. Better examples to improve utility. Reinforces need for management support. Strengthens linkage between DFMEA/PFMEA. Ranking tables better reflect real world use. Introduces alternative methods in use. Suggests better means than RPN to assess risk. Recommends against threshold RPN values to initiate required action. Process FMEA Report POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (Process FMEA) Item _________________________________ Model Year(s) Program(s) ________________ Process Responsibility ______________________ Key Date _________________________________ FMEA Number ___________ Page _____ of ______ Prepared by _________________________ FMEA Date (Orig.) _______ (Rev.) _______ Core Team _________________________________________________________________________________________________________________________ Process Step Function Potential Failure Mode C Potential O Current S l Causes/ a c Process e Mechanisms Control v s of Failure c s (Prevention) Action Results Current Process Control (Detection) D e t R. P. N. Recommended Actions Responsibility & Target Completion Date Actions Taken S O D e c e v c t R. P. N. Potential Effects of Failure Process FMEA Analysis Process Step Function Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. Process Step is simply the focus of the analysis Describe how the item could potentially fail to perform its function Identify potential causes of the item not performing its intended function This column is used to document methods that have been used to detect either the cause or the failure mode State the effects of the failure in Describe terms of the specific the function or system, subsystem, requirement to or component be analyzed being analyzed This column is reserved for the methods that have been used to prevent a specific cause Process FMEA Analysis Process Step Function Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. Severity evaluates the impact of the effect. Occurrence rates how often a specific cause is likely to result in the failure mode being analyzed. Detection ranks our ability to detect either a cause or a resulting failure mode. Use best detection available. Classification is an optional column commonly used to identify safety risks. Risk Priority Number is the product of the severity, occurrence, and detection rankings. Four Common Classes of FMEA • System FMEA – Focuses on how interactions among systems might fail. • Design FMEA – Focuses on how product design might fail. • Process FMEA – Focuses on how processes that make the product might fail. • Machinery FMEA – Focuses on how machinery that perform processes might fail. The focus for this evening is on Process FMEA. AIAG Model for Quality Planning Design FMEA Process & Machinery FMEA Understanding a Failure Sequence Cause Detection Failure Mode Detection Direct Cause Failure Mode Immediate Effect Is it a Cause or Failure Mode? System Level Failure Modes Effects Causes Subsystem Level Failure Modes Effects Causes Component Level Failure Modes Effects Causes Examples of Weld Process Failure Modes • System (Welding Line) – Robot Failure – Loss of Incoming Water – No Signal to Weld • Subsystem (Weld Gun) – Cracked Jaw – Failed Servo Motor – Failed Shunt • Component (Servo Motor) – Overheats – Loss of Position – Premature Seal Failure 12 A Rational Structure for Quality Planning TM Product Product Design FMEA Design FMEA Process Process Process FMEA Process FMEA Customer Plant Customer Plant Control Plan Control Plan Tool Tool Design Design Machinery FMEA Machinery FMEA Internal Internal Processes Processes Process FMEA Process FMEA Internal Internal Process Process Control Plan Control Plan Motivation for Specific FMEAs Life Cycle Cost Product Design FMEA Process Process FMEA Tool Design Machinery FMEA Internal Processes Process FMEA Internal Process Control Plan Customer Satisfaction R&M Customer Plant Control Plan First-Time Capability DFMEA Information Linkages The Underlying Message • Don’t correct a weak product design by focusing on a super robust process. • Don’t correct a weak process design by focusing on design changes to the product. PFMEA Information Linkages Rational Structure and Project Specific Control Plans Product Design FMEA Process Process FMEA Identify and Manage Deliverables Customer Required for Plant Design Review Control Plan Identify and Manage Information Required for Contract Review Tool Design Machinery FMEA Internal Processes Process FMEA Internal Process Control Plan Identify and Manage Deliverables Required for Build & Buy-Off Three Phases of Control Plan Phase 1 Control Plan for Prototype Product Design FMEA Phase 2 Control Plan Process for Process FMEA Pre-Production Tool Design Machinery FMEA Internal Processes Process FMEA Internal Process Control Plan Customer Plant Control Plan Phase 3 Control Plan for Production Containment Considerations • • • • • • • Cost of Defects Risk of Defects Bracketing Strategies Protecting On-Time Delivery Cost of Stopping Production Cost of Recall Campaigns Benefits of Traceability FMEA Teams • Multi-functional teams are essential. • Ensure expertise from manufacturing engineering, plant operations, maintenance, and other appropriate sources. • Select team with ability to contribute: – – – – – Knowledge Information Experience Equity Empowerment • Pick the right team members, but limit the number of team members based on the scope of the issues being addressed. • In addition to the FMEA team. – Call in Experts as Needed Relevant Resources and Expertise Common Team Problems • • • • • • • • • No Common Understanding of FMEA Overbearing Participants Reluctant Participants Opinions Treated as Facts Rush to Accomplishments Digression and Tangents Hidden Agendas Going through the Motions Seeing FMEA as a Deliverable A Process Flow for FMEA 1. Define the Scope • Scope is essential because it sets limits on a given FMEA, that is, it makes it finite. • Several documents may assist the team in determining the scope of a Process FMEA: – – – – Process Flow Diagram Relationship Matrix Drawings, Sketches, or Schematics Bill of Materials (BOM) Process Flow Charts High Level Flow Chart Detailed Flow Chart 2. Define the Customer • Four major customers need to be considered: – – – – End Users OEM Plants Supplier Plants Government Agencies (safety and environment) • Customer knowledge can contribute precise definition of functions, requirements, and specifications. 3. Identify Functions, Requirements, Specifications • Identify and understand the process steps and their functions, requirements, and specifications that are within the scope of the analysis. • The goal in this phase is to clarify the design intent or purpose of the process. • This step, well done, leads quite naturally to the identification of potential failure modes. Defining Functions • • • • • Describe the Functions in Concise Terms Use “Verb-Noun” Phrases Select Active Verbs Use Terms that can be Measured Examples: – Pick and Place Unit Secure Part Advance Part Locate Part Position Weld Gun – Robot Process Steps, Functions, Requirements Process Steps Functions Requirements Process and Functional Requirements Identify Process and Function – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size - Hole location - Free of burrs Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. Identification of Failure Modes Omission of an Action Functional Requirements Incorrect Actions Function Not Done Function Done Poorly Surprise Results Correct Actions Example: Failure Modes Color Change System Spray Paint Failure Modes No Paint Spitting Paint Stream of Paint Too Much Paint Too Little Paint Void in Fan Function Dispense Paint Properly Example: Failure Modes Color Change System Measure Fluid Flow Function Failure Modes No Feedback Signal Intermittent Signal Signal Too High Send Accurate Feedback Signal Signal Too Low Feedback Signal with No Flow Flow Meter Restricts Flow Example of Failure Modes Example of Failure Modes Identify Process and Function – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size Potential Failure Mode Potential Effects of Failure S e v C Potential l O Causes/ a Mechanisms c s c of Failure s Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. No hole Hole too large Hole too small Hole violates MMC boundary - Hole Depth Hole not drilled thru - Hole location - No burrs Failure Mode Identification Worksheet Process Step: Potential Failure Modes Functional requirements or specifications: 5. Identify Potential Causes • Potential cause of failure describes how a process failure could occur, in terms of something that can be controlled or corrected. • Our goal is to describe the direct relationship that exists between the cause and resulting process failure mode. • Document a unique failure sequence with each potential cause. Causes Causes Precede the Failure Mode Direct Cause Direct Cause Failure Mode Immediate Effect Direct Cause FMEA Worksheet Form Transfer of Failure Mode to Worksheet Example of Causes Example of Causes Identify Causes of Failure – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size Potential Failure Mode Potential Effects of Failure S e v C Potential l O Causes/ a Mechanisms c s c of Failure s Feed rate too high Spindle speed too slow Wrong drill size Drill improperly sharpened Wrong tool geometry for material Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. Hole too large - Hole depth Hole not drilled thru Missing drill 6. Identify Potential Effects • Potential effects of a process failure are defined as the result of the failure mode as perceived by the customer. • The intent is to describe the impact of the failure in terms of what the customer might notice or experience. • This applies to both internal and external customers. Causes and Effects Effects are the Result of the Failure Mode Causes Precede the Failure Mode Immediate Effect Direct Cause Failure Mode Immediate Effect Immediate Effect Two Focal Points for Effects An effect is the immediate consequence of the failure mode. • What is the pain that is felt by the end user? • What is the pain felt by downstream manufacturing or assembly operations? Example of Effects Example of Effects Identify Effects of Failure – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size Hole too large Bolt may not hold torque Violation of specification Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Feed rate too high Spindle speed too slow Wrong drill size Drill improperly sharpened Wrong tool geometry for material - Hole depth Hole not drilled thru Assemble with missing fastener Missing drill Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. 7. Identify Current Controls • Current Process Controls describe planned activities or devices that can prevent or detect the cause of a failure or a failure mode itself. • There are two classes of controls: – Preventive controls either eliminate the causes of the failure mode or the failure mode itself, or reduce how frequently it occurs. – Detective controls recognize a failure mode or a cause of failure so associated countermeasures are put into action. • Preventive controls are the preferred approach because they are most cost effective. Two Types of Detection Cause Detection • Go/NoGo Gage Failure Mode Detection • Set-Up Validation Sign-Off Direct Cause Wrong Nozzle in Bin Failure Mode Wrong Paint Nozzle Immediate Effects Paint Splatter Too Much Paint Too Little Paint Example of Process Controls Example of Process Controls Identify Current Controls – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size Hole too large Bolt may not hold torque Violation of specification Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Feed rate too high Spindle speed too slow Wrong drill size Dull drill bit Drill improperly sharpened Wrong tool geometry for material DOE Results Current Process Control (Prevention) DOE Results DOE Results Current Process Control (Detection) Set Up Verification Set Up Verification First Piece Inspection Load Meter Set Up Verification Set Up verification D e t R. P. N. 8. Identify and Prioritize Risk • Risk in a Process FMEA is identified in three ways: Severity – which measures the effect. Occurrence – to assess the frequency of causes. Detection – ability to detect causes or failures. • It is appropriate to assess these three scores through the understanding of your customer’s requirements. Severity of Effect Frequency of Occurrence Detection by Current Control Assess Severity, Occurrence, Detection Process Step Function Potential Failure Mode Potential Effects of Failure S e v C l a s s Potential O Causes/ Mechanisms c c of Failure Current Process Control (Prevention) Current Process Control (Detection) D e t R. P. N. Severity evaluates the impact of the effect. Occurrence rates how often a specific cause is likely to result in the failure mode being analyzed. Detection ranks our ability to detect either a cause or a resulting failure mode. Use best detection available. Example of Severity, Occurrence, Detection Example of Severity, Occurrence, Detection Prioritization of Risk Several strategies exist for the mitigation of risk, for example: 1. High Risk Priority Numbers 2. High Severity Risks (regardless of RPN) 3. High Design Risks (Severity x Occurrence) 4. Other Alternatives (S,O,D) and (S,D) NOTE: “The use of an RPN threshold is NOT a recommended practice for the need for action.” Identify Current Controls – Traditional Format Process Step Function Clearance hole for 12 mm bolt - Hole size Potential Failure Mode Potential Effects of Failure S e v C Potential l O Causes/ a Mechanisms c s c of Failure s Current Process Control (Prevention) Current Process Control (Detection) Set Up Verification Set Up Verification First Piece Inspection Load Meter Set Up Verification Set Up verification D e t R. P. N. Hole too large Bolt may not 5 hold torque Violation of specification Feed rate too 2 DOE Results high Spindle speed 2 DOE Results too slow Wrong drill size Dull drill bit 2 4 5 5 5 2 5 5 50 50 50 40 50 50 Drill improperly 2 sharpened Wrong tool 2 DOE Results geometry for material 9. Recommend Actions • The intent with recommended actions is to reduce risk. • Recommended actions will be focused to: – Reduce Severity – Reduce Frequency of Occurrence – Improve Detection Managing Recommended Actions • Transfer FMEA action items onto the mechanism used to track and ensure closure of open issues on the project. • Decisions to take different actions or not to act must be approved. • Review status of FMEA action items on a regular basis. Recommended Actions Action Results Recommended Actions Responsibility & Target Completion Date Actions Taken S O D e c e v c t R. P. N. 10. Verify Results • Whenever you change a process one of two things happen: – Things Get Better – Things Get Worse • Verify actual performance following the implementation of the recommended actions. Summary and Closure Key Points to Remember Upon successful completion of this course, you should know: 1. 2. 3. 4. 5. 6. 7. 8. Potential FMEA Reference Manual is the authoritative reference. Severity scores of 9 or 10 must be used for safety related risks. Occurrence ranks how often each cause is likely to result in failure. It is appropriate to focus on high severity items first. Credit for preventive actions shows up in the frequency of occurrence. Risk Priority Numbers provides a rank order to risks and action items. An effective approach is to continually focus on the top five concerns. Process FMEA should result in tangible improvement to process performance. Questions and Answers Please type your questions in the panel box Thank You For Attending Please visit our website www.asq-auto.org for future webinar dates and topics.
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