Process Failure Modes And Effects Analysis

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Process Failure Modes andEffects AnalysisPFMEA for SuppliersCopyright 2003-2007 Raytheon Company. All rights reserved.R6σ is a Raytheon trademark registered in the United States and Europe.Raytheon Six Sigma is a trademark of Raytheon Company.R6s is a trademark of Raytheon Company.

Process Failure Modes and Effects AnalysisA structured approach that ensures potential process failure modesand their associated causes have been considered andaddressed in the design of the process– What can go wrong?– Where will the variation come from?– How can we prevent or control?Copyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 2

Overview of the PFMEA Process People knowledgeable about the process analyze situations wherecritical customer requirements might not be met A ranking system is used to estimate three factors:– how Severe the failure would be– how frequently the failure would Occur,– how difficult it would be to Detect, and The S/O/D factors are multiplied; the resulting value is called the RiskPriority Number (RPN) The RPN is used to prioritize the failure modes so that corrective actionscan be taken to reduce the frequency, severity and/or improve thedetectability of the failure mode PFMEA output is the starting point for the– Process redesign/leaning– Control Plan– Out-of-Control Action Plan (OCAP)Copyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 3

PFMEA Benefits Disciplined approach for identifying the ways a process design can failbefore impacting the customer or the product function– Identifies potential manufacturing and/or assembly process failures– Identifies the significant process variables to control to reduce occurrence andimprove detection of failure conditions Rational prioritization of potential failures for corrective/preventive actionand/or redesign Helps to identify critical process parameters Provides critical input for the process control plan Opportunity to collaborate with and influence Raytheon designers toeliminate problems before they occur in your production line Smoother production ramps Reduced development, production and warranty cost Higher customer satisfactionCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 4

PFMEA Prerequisites Select proper team and organize members effectively Select teams for each process Create/agree on a ranking system Agree on format for the PFMEA matrix Define the customer and customer needs/expectations Define the process requirements Map the baseline process with a flow chartCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 5

PFMEA Flow4 Create action planto reduce RPN3 Assign S/O/D ratings5 Drive actionsCalculate RPNto resolution2 Map the6 Implementprocesscontrols1 Assemblethe team7 Re-baselineRPNsFAILURE MODE: How a product can fail to meet design specifications or functional intentCAUSE: A deficiency that results in a failure mode Î e.g. sources of variationEFFECT: Impact on customer if the failure mode is not prevented or correctedCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 6

Typical PFMEA Team Members Process Engineer - Generally the Team Leader Production Operators Industrial Engineer Design Engineer Quality Engineer Reliability Engineer Tooling Engineer Maintenance Engineer Project Manager Others including Sales, QA/QC, OperationsCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 7

Creating the Process Map Identify the process to map Ask the people most familiar with the process to help construct the map Agree on the start and end points; defining the scope of the process to bemapped is important, otherwise the task can become unwieldy Agree on the level of detail to use; it’s better to start out with less detail,increasing detail only as needed to accomplish your purpose Identify the sequence and the steps taken to carry out the process; walk the lineif necessary Construct the process map either from left to right or from top to bottom, usingstandard flow chart symbols and connecting the steps with arrows Identify key process characteristics as potential sources of failure––––Is the process standardized, or are the people doing the work in different ways?Are steps repeated or out of sequence?Are there steps where errors occur frequently?Are there rework loops? Analyze the results and document potential failure modes at each process stepCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 8

Process Map ExampleHV Capacitor: High Level Process MapWindingCuringSwage &AssembleSolder toCoversWO issue& kittingWeldcoverImpregnationSealWeld cans,blanks& coversBrazeterminalsWeld backplates &canClean can& coverNote: Test points are at winding, curing, assembly, weld, impregnation and sealCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 9

Organizing Information Using the PFMEATemplate List each process step from the process map Describe the potential failure modes for each process step Identify the impact of each potential failure mode on downstreamprocesses, product functionality or the customer experience Identify likely causes in the process for these failure modes Describe the current process controls—if they exist—that are in place tocontain the causes Assign appropriate values to Severity/Occurrence/Detectability to obtainRPN (note: scale descriptions are included in PFMEA template)– Severity: Scale 1-10, 1 no impact, 10 catastrophic impact/hazardous– Occurrence: Scale 1-10, 1 predicted 3 defects/million, 10 500Kdefects/million– Detectability: Scale 1-10, 1 always detected by current control plan,10 unable to detect Sort process steps by RPN number high-to-low to prioritize the actionplan for maximum impactCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 10

PFMEA TemplatePFMEA TemplateCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 11

PFMEA ExampleCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 12

Potential Process Failure Causes Omitted processing Poor control procedures Processing errors Improper equipment maintenance Errors setting up work pieces Bad recipe Missing parts Fatigue Wrong parts Lack of Safety Processing wrong work piece Hardware failure Mis-operation Failure to enforce controls Adjustment error Environment Equipment not set up properly Stress connections Tools and/or fixtures improperlyprepared Poor FMEA(s)Copyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 13

PFMEA S/O/D RatingsSeverityCopyright 2003–2007 Raytheon Company. All Rights Reserved.OccurrencePage 00 - 14Detectability

Defining the Action Plan If the control plan for the process step is adequate, no further action required(typically if RPN value is 20) If the control plan for the process step is inadequate:– Identify differences between the current and the desired situation– Determine how the failure can be better contained and/or eliminated Consider implementation of new or more effective process controls Assess if process steps that don’t add value to the output can be eliminated Determine if design modification is effective at eliminating or reducing occurrence ordetectability of the failure mode, and if it can be accommodated Document plan and reassess S/O/D and RPN values; is it enough? Separate between– Supplier actions– Raytheon actions– Joint actions Publish result and include in quote/feedback to Raytheon Engineering andProcurement teams Manage to the planCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 15

Potential Process Controls Standardized workinstructions/procedures Fixtures and jigs Mistake-proofing tooling and/orproduct design Marking Training and related educationalsafeguards Visual checks Post process inspection/testing Mechanical interference interfaces Gage/MSA studies Mechanical counters Statistical Process Control Mechanical sensors Design of experiments on theprocess/Robust process design Electrical/Electronic sensors Job sheets or Process packages Preventive maintenance Bar coding with softwareintegration and control Automation & Real Time ControlCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 16

PFMEA as Part of ISO9001StatisticalProcessControlProcessFailureMode andEffectsAnalysisMeasurementSystemAnalysisQuality SystemAnalysisISO-9001QS-9000Advanced ProductQuality Planning &Control PlanCopyright 2003–2007 Raytheon Company. All Rights Reserved.Production PartApproval ProcessTooling andEquipment SupplementPage 00 - 17

Linkage to Raytheon PFMEA is a team effort Promotes actionable input to the design phase– Designs can and do impact ability to execute processes, and vice versa Enables suppliers to add value and influence designs by highlighting functionalconcerns earlier in the design/development process The risk of some failure modes will be associated with:–––––––Supplier process capabilitiesNon value-added stepsMaterial or finish selectionDesign requirementsMaterial flowsRework flowsTest and/or detection strategies and capabilities Mitigation action plans could include:– Supplier actions– Joint Raytheon/supplier actionsCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 18

ResourcesTextbooks: Failure Mode and Effect Analysis: FMEA from Theory toExecution; Author: D.H. Stamatis The Basics of FMEA; Authors: Robin E. McDermott, Raymond J.Mikulak, Michael R. BeauregardOn the Web: http://www.fmeainfocentre.com/– http://www.fmeainfocentre.com/examples.htm http://www.isixsigma.com/tt/fmea/ lysistools/overview/fmea.htmlCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 19

EndCopyright 2003–2007 Raytheon Company. All Rights Reserved.Page 00 - 20

Template List each process step from the process map Describe the potential failure modes for each process step Identify the impact of each potential failure mode on downstream processes, product functionality or the customer experience Identify likely causes in the process for these failure modes

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