PROCESS. Failure Mode & Effects Analysis. Practitioner Guide

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1 TOOLKIT PROCESS Failure Mode & Effects Analysis Practitioner Guide Creating and managing effective Part Number Specific Process FMEAs using Reference (Unit) FMEAs Dr. Ian Riggs

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3 Contents LIST OF FIGURES 5 LIST OF TABLES 6 INTRODUCTION 7 Chapter One 11 PROCESS FMEA AS PART OF A DEFECT PREVENTION SYSTEM 11 THE DESIGN FMEA 12 THE PROCESS FMEA 14 THE CONTROL PLAN 17 MEASUREMENT SYSTEMS ANALYSIS 18 INITIAL CAPABILITY & PROCESS CONTROL 20 Chapter Two 23 PROCESS FMEAS KEY POINTS & CARE POINTS 23 CROSS FUNCTIONAL TEAM APPROACH 23 PFMEA SCOPE 23 A) PART NUMBER & DESCRIPTION 25 B) CORE TEAM 27 C) ORIGINAL DATE / REVISION DATE 28 D) OPERATION / STEP 29 E) PROCESS FUNCTION / REQUIREMENT 30 F) POTENTIAL FAILURE MODES 33 G) POTENTIAL EFFECT OF FAILURE 34 H) SEVERITY RATING 35 I) POTENTIAL CAUSE(S) OF THE FAILURE MODE 36 J) PREVENTION CONTROLS 38 K) OCCURRENCE RATING 39 L) DETECTION CONTROLS 41 3

4 M) DETECTION RANKING 42 N) RISK PRIORITY SCORE 43 O) IMPROVEMENT ACTIONS 45 PFMEA RPN SCORING WORKED EXAMPLE 47 Chapter Three 51 CREATING REFERENCE PROCESS FMEAS 51 STEP 1: SELECT THE PROCESS FOR EVALUATION 52 STEP 2: DEFINE THE TYPICAL FEATURES AND CHARACTERISTICS OF THE PROCESS BEING EVALUATED 52 STEP 3: DEFINE TYPICAL FAILURE MODES FOR EACH CHARACTERISTIC 53 STEP 4: IDENTIFY POTENTIAL CAUSES OF FAILURE BY PROCESS TYPE 54 STEP 5: IDENTIFYING THE PREVENTION CONTROLS ALIGNED TO THE IDENTIFIED POTENTIAL CAUSES IN THE REFERENCE PFMEA 56 STEP 6: IDENTIFYING THE TYPICAL DETECTION CONTROLS FOR THE FAILURE MODE IN THE REFERENCE PFMEA 57 Chapter Four 59 COMPLETING A PFMEA USING REFERENCE PFMEAS BUILDING BLOCKS 59 STEP 1: SELECT THE PART NUMBER FOR THE PFMEA ACTIVITY & COLLATE ALL RELATED DOCUMENTATION REQUIRED TO COMPLETE THE PFMEA 60 STEP 2: COMPLETE THE PROCESS STEP AND REQUIREMENT COLUMNS OF THE PFMEA USING THE INFORMATION COLLECTED IN STEP STEP 3: ADD THE RELEVANT REFERENCE PFMEA INFORMATION FOR EACH CHARACTERISTIC LISTED. 63 STEP 4: COMPLETE THE PART SPECIFIC PFMEA WITH CROSS FUNCTIONAL TEAM 66 STEP 5: PRIORITISING IMPROVEMENT ACTIONS 70 APPENDIX A: ROLLS-ROYCE PFMEA SCORING GUIDELINES 70 APPENDIX B: TYPICAL FAILURE MODE LIBRARY 73 APPENDIX C: KEY QUESTIONS FOR PFMEA 74 4

5 List of Figures Figure 1: PFMEA Template from AS Figure 2: Creating Part Specific PFMEAs Overview using Reference PFMEAs 10 Figure 3: Advanced Quality Product Planning Key Elements 11 Figure 4: Role of the Design FMEA 12 Figure 5: The Role of the Process FMEA 14 Figure 6: Typical Control Strategies based upon the PFMEA Risk Profile 15 Figure 7: Standard Control Plan Template 17 Figure 8: Sources of Measurement Error 18 Figure 9: The Effect of Gauge R&R Result on the Engineering Tolerance in manufacturing The Zone of Uncertainty 19 Figure 10: Processes On Target with Minimum variation 20 Figure 11: Calculating Cpk for a Process 21 Figure 12: Impact of Cpk per feature on Part Right First Time & Parts per Million (PPM) 21 Figure 13: Relationship between Cpk, 6 Sigma and Parts per Million 22 Figure 14: Process FMEA example (truncated) 24 Figure 15: Team Size Effectiveness 27 Figure 16: Process Function and link to Potential Failure Modes in a PFMEA 31 Figure 17: Potential Causes of Failure in a PFMEA 36 Figure 18: RPN Scoring Example 43 Figure 19: RPN Improvement Actions in a PFMEA 46 Figure 20: Detection Scoring Analogy 49 Figure 21: Overview of Reference PFMEA Elements 51 Figure 22: Reference PFMEA for CNC Hole Drilling: Potential Failure Mode Causes 55 Figure 23: Reference PFMEA Prevention Controls 56 Figure 24: Identifying the Typical Detection Controls in the Reference PFMEA 58 Figure 25: Reference PFMEA Database Structure Example 60 Figure 26: Completing the Process Step and Requirements Column 61 Figure 27: Hole Pattern Example 62 Figure 28: Determining the Required Reference PFMEAs 63 Figure 29: Compiling the Shell Part Number PFMEA using Reference PFMEAs 64 Figure 30: Reference PFMEA example 65 Figure 31: Completing the Effects and Severity Rating 66 Figure 32: Completing the Potential Causes, Prevention Controls and Occurrence Scoring sections. 67 Figure 33: Updating the Detection Controls, Detection Scoring and calculating the RPN 68 Figure 34: Documenting Improvement Actions and Rescoring RPN 69 5

6 List of Tables Table 1 : Failure Mode Examples 33 Table 2 : AS13004 Process FMEA Severity Risk Scoring 35 Table 3 : AS13004 Occurrence Rating Table for Process FMEA 40 Table 4 : AS13004 Detection Rating Table 42 Table 5: Example Failure Modes 53 6

7 Introduction Creating Effective Process FMEAs Failure Mode and Effects Analysis (FMEA) is a core defect prevention tool and one of the most effective of all quality activities. It can also be one of the most difficult to deploy effectively as it relies not only on technical knowledge and experience but precision of language and the right level of detail. The purpose of this guide is to help the business to understand the key success factors and care points in creating effective Process FMEAs (PFMEAs). This step by step practitioner guide will describe the process for completing a Part Specific Process FMEA using pre-defined Reference (Unit) PFMEA building blocks. The approach described in this guide is aligned with the AIAG Manuals, Potential Failure Mode & Effects Analysis (PFMEA) and Advanced Product Quality Planning & Control Plans (APQP). It also supports the AESQ Standard AS13004 Managing Process Risks and Control Plans. For Process FMEAs to be effective following rules must be adhered to; The PFMEA must be part number specific. The PFMEA must consider all design features and characteristics on the drawing and related specifications. The PFMEA must include all process steps from Receipt through to Despatch, where the product is transformed. Improvement actions must be identified and implemented for High Severity and High Occurrence risks identified within the PFMEA. The PFMEA template must be as defined within the AS13004 standard (see Figure 1). Under no circumstances should any deviation from this standard template be allowed e.g. addition of extra columns, etc. To ensure that the PFMEA is efficient then the following guidelines should be adhered to; Part Number PFMEAs should be created using standard Reference PFMEAs. This enables the best practice solutions to be shared for all new PFMEAs and is the most efficient way of avoiding a duplication of effort. Reference PFMEAs and Part Number PFMEAs should be created in a dedicated FMEA software tool that can manage the complexity and volume of data created across all part numbers. For Rolls-Royce xfmea is the software of choice. There are many other FMEA software solutions available. 7

8 The Reference PFMEAs shall be maintained by a single function to ensure consistency and version control. Within Rolls-Royce this shall be done by the Global Process Owners, part of the Corporate Manufacturing Engineering function. If there is no defined Reference PFMEAs available then the team that requires it shall first create it and then make it available to the other parts of the business using the standard FMEA software e.g. xfmea. Care must be taken to avoid the duplication of the creation of Reference PFMEAs across the business. This must be controlled centrally through the Manufacturing Engineering Function. The Business must establish a cohort of engineers that are trained in FMEA and the chosen FMEA software tools to support the process. Dr. Ian Riggs Head of Quality Assurance, Audit & Zero Defects Program 8

9 Figure 1: PFMEA Template from AS13004 Process Failure Mode and Effects Analysis (PFMEA) Prototype - Pre-Launch- Production - X Process Engineer 07/24/20x x Key Contact / Phone Date (Orig.) Date (Rev.) N/C Part Number M21345 Core T eam Operator, Process Engineer, Quality Engineer, Operation MGR Customer Approval Date Note: This is not a complete PFMEA document, as several process steps, failure modes, effects and controls have been omitted from this example to aid clarity for the standard. All process steps and relevant failure modes, associated effects and controls would be shown within a typical FMEA for this product 08/15/20x x Current Process Action Results Occurrence Detection Severity Occurrence Detection Process Function/ Potential Potential Effect(s) of Failure Operation Step Requirements Description Failure Mode Potential Cause(s) of Failure Prev ention Controls Detection Controls Responsibility RPN Recommended Action & Target Actions Taken Completion Date Completion Date RPN Correct tools loaded Part Leaks, resulting in fuel leak leading to fire, explosion or safety in position to drill to CNC Drill -Set- Over High hazard (10) Incorrect drill loaded into tool Laser tool check prior to machining 2 Set-up CNC Drill si ze 10 KC Up Limit Reject Sent to Customer (8) magazine operation (0.375 in / - Scrap at plant w/o late delivery (6) in) External company contacted, solution identified Visual inspection (8) Implement functionality to automatically Process Engineer and target date for implementation set In process inspection and stop the machining operation following # /15/20xx (06/02/20xx). Action to be closed 09/25/20xx Final inspection with CMM (6) the failure of a laser tool check. following verification of implemented solution CNC Drill -Set- Up Reject Sent to Customer, unable to assemble tube or adaptor at Under Low Incorrect drill loaded into tool Laser tool check prior to machining engine assembly facility (8) 8 KC Limit magazine operation Reworkable but with impact to delivery (6) External company contacted, solution identified Visual inspection (8) Implement functionality to automatically Process Engineer and target date for implementation set In process inspection and 6 96 stop the machining operation following /15/20xx (06/02/20xx). Action to be closed 09/25/20xx Final inspection with CMM (6) the failure of a laser tool check. following verification of implemented solution. Operator cleans chips from fixture Reject Sent to Customer, unable to assemble tube or adaptor at Part moved in Fixture due to prior to loading CNC Drill - Drill Holes to correct Holes out of 3 Set-up CNC Drill engine assembly facility (8) 8 KC cutting chips preventing part Load Material location position Scrap at plant w/o late delivery (6) seating properly Operator visual inspection of fixture contamination prior to loading Visual inspection (8) Implement automated fixturing In process inspection and Process Engineer Design activity in work - new Occurrence techniques that flush chips from fixture Final inspection of hole position with CMM 03/25/20xx estimated to be 2 06/15/20xx prior to part being loaded (6) Fixture box protection in place on location points Part incorrectly located in 8 KC fixture due to fixture damage Operator visual inspection of fixture for damage prior to loading Visual inspection (8) In process inspection and 6 96 Final inspection of hole position with CMM (6) Reject Sent to Customer, unable to assemble tube or adaptor at Tool life limited to 10 parts / tool Implement tool torque limiter to stop Update - talked to vendor of CNC machine and CNC Drill - Drill Drill Holes Holes not Process Engineer 4 Drill Holes engine assembly facility (8) 8 KC Worn/Damaged drill Laser tool check prior to machining 3 In Process and Final Visual Inspection (7) machining operation prior to tool currently identifying means of implementing Holes Completely Thru Drilled Thru 03/15/20xx Reworkable but with impact to delivery (6) operation breakage monitoring system on existing machines Change CNC program to lower occurrence by building an autodeburring cycle into the drilling Deburr - Fuel-Air Process Engineer Program Modified Deburr 1 Remove Burrs Over Deburred Scrap at plant w/o late delivery (6) 6 Manually dependent process None 3 In Process and Final Visual Inspection (7) Operation Bracket 09/15/20xx 09/15/20xx Consider implementation of robot deburring. Change CNC program to lower occurrence by building an autodeburring cycle into the drilling Under Process Engineer Program Modified Reworkable but with impact to delivery (6) 6 Manually dependent process None 2 In Process and Final Visual Inspection (7) 7 84 Operation Deburred 07/24/20xx 09/15/20xx Consider implementation of robot deburring. Outside Processing - Part not Reject Sent to Customer (8) Hard Anodize 1 Fuel-Air Bracket; Hard Anodize Part anodized Reworkable but with impact to delivery (6) Anodize Process flow step missed (part Operator stamp required on each not sent to be anodized) step in the router Visual check of part at final inspection (without visual acceptance standards in place) 7 56 Compliance check with Certificate of Conformance Manually dependent process, Cleaning - Fuel-Air Part not Operator stamp required on each Cleaning 1 Clean Part Reworkable but with impact to delivery (6) 6 process not adequately Bracket cleaned step in the router completed Visual assessment of part cleanliness in 7 42 final inspection (7) Cleaning solution Regular change of cleaning solution contaminated every 100 parts or 1 month Visual assessment of part cleanliness in 7 84 final inspection (7) Incorrect Data Mark Parts - Fuel-Air Reject sent to customer (8) Part Marking 1 Mark Parts per Print Marked on the Bracket Reworkable without impact to delivery (4) Part Implement automated part marking system with data pulled directly out of database avoiding the need for manual Marking information entered Visual confirmation of marked data in final Process Engineer None transcription. Cell procured and being installed 06/01/20xx manually - Incorrect entry inspection (7) 06/01/20xx Station to include automated in station control (scanning and confirmation of barcode) Marking not in Reject sent to customer (8) correct Reworkable without impact to delivery (4) location Part not located correctly in Visual inspection of mark position using Implement location fixture on marking Process Engineer None Procured and being installed 05/15/20xx marking machine reference overlay template (7) machine. 05/15/20xx Parts not Pack Parts - Fuel-Air Pack parts for Insufficient protective material Implement molded polystyrene Process Engineer New packaging introduced Packing 1 packed Part damaged in transit, Damaged part delivered to customer (8) 8 None 2 Visual confirmation of packaging (7) Bracket Shipping included in box protection. 09/30/20xx 09/30/20xx properly Severity Classification 9

10 An overview of the process to creating Part Number Specific PFMEAs is shown in Figure 2 and is described in detail in Chapter Four. Figure 2: Creating Part Specific PFMEAs Overview using Reference PFMEAs Required documentation includes: Drawings Related Specifications Process Flow Chart Characteristic Matrix Non-conformance history of similar parts Select Part Number for PFMEA Collate all required documentation for Part Number Review availability of Reference PFMEAs Available? yes no Create Reference PFMEAs & update database Create PFMEA shell with specific features and Reference PFMEAs Complete PFMEA shell with Cross Functional Team Identity Improvement Actions and Implement Cross Functional Team Activity 10

11 Chapter One Process FMEA as part of a Defect Prevention System Process FMEAs are a key defect prevention tool and are one of the foundational activities within Advanced Product Quality Planning (APQP). APQP is a system of interconnecting quality tools designed to ensure that product and process designs are created that meet the customer s requirements. Deployed properly it is one of the most effective ways of designing production processes that are capable of achieving Zero Defects. APQP is conducted on a specific part number or assembly and follows a series of activities from concept design through to manufacturing validation (Production Part Approval Process (PPAP). The purpose of these tools is to identify potential risks with the product and process design at a point in time where changes to either the product or process can still be made to address any identified issues. Although there is still value in the use of these tools retrospectively clearly their ability to change the product or process design to mitigate any risks will be more difficult. APQP contains a number of activities but the core Quality Tools are shown in Figure 3. It is important to note that the strength of the effectiveness of these tools relies on them being used as a system and not as stand-alone activities. Also to get the best from these tools it is vital to establish cross-functional team work that includes all of the key knowledge and experience of the product and process being evaluated. Figure 3: Advanced Quality Product Planning Key Elements Product Design Process Design Production and Service Integrated Product & Production Readiness (IPPR) (APQP) & Production Part Approval Process (PPAP) Design FMEA Process FMEA Control Plan MSA Capability Error Proofing Process Control (SPC) Ship 8D Problem Solving The following pages provide an overview of each of these quality tools and how they link together. 11

12 The Design FMEA Figure 4: Role of the Design FMEA (1) Customer Defines Functional Requirements (2) Design Engineering Create a Product Design to meet the Customer s Functional Requirements (3) Design FMEA Evaluates how the Design Process may fail to produce a Product Design that meets the Functional requirements of the Customer Outputs of the DFMEA are the Design Verification Plan, Key Characteristics List and Design Improvement plans Key Characteristics List PFMEA Consequences of Product Failure information The Design FMEA evaluates the proposed design to identify and mitigate the ways in which the design may fail to meet the Functional Requirements of the customer. For example the customer may specify that an engine must have a fuel efficiency of X. The Design FMEA will evaluate how the design may fail to achieve this requirement. The Failure Mode in this case would be Fuel efficiency specification not met. For a component such as a pipe the customer requirement may be to transfer water at 50 litres per second at a pressure of 50 bar. In this example one of the Design Failure Modes would be unable to transfer 50 litres of water per second. The DFMEA will then proceed to look for ways in which the Design could fail to meet these requirements i.e. the Potential Causes. For the pipe example this may include specified pipe inner diameter too small. When completing a DFMEA the team must assume that the part will be made correctly. Manufacturing failures to meet specification must not be listed as Potential Causes of Failure Modes. 12

13 The DFMEA will then identify the prevention and detection controls within the design process to mitigate the potential for this design failure e.g. computer modelling, prototype testing, etc. This will form the basis of the Design Verification program. The DFMEA will produce a list of key risks (Risk Priority Numbers or RPNs) that the team will need to address during the design phase i.e. eliminating the risk or mitigating it. Another output from the Design FMEA will be the key design characteristics that have been identified and will have an impact on Safety and/or performance of the product to the customer. Information from the DFMEA can also be used to inform the Process FMEA of the effects and severity of specific product Failure Modes. It should be noted however that simply reviewing the DFMEA when compiling the Process FMEA will not be straight forward. The DFMEA is a good input for the Design Engineer to bring to the PFMEA session but the team will need the Engineer s knowledge to interpret the DFMEA for use with the PFMEA. Where no Design FMEA is available then the Design Engineering team will need to provide support to the Process FMEA through providing an engineering knowledge. 13

14 The Process FMEA Following the completion of the DFMEA and before the Engineering definition is finalised there are many opportunities for the Design and Manufacturing Engineering teams to collaborate and through processes such as Design for Manufacture and Assembly ensure that the Design is feasible and has learnt from previous lessons. Figure 5: The Role of the Process FMEA OP10 OP20 OP30 OP40 OP50 OP60 (1) Design Engineering Define Drawing & Specifications To meet Customer Requirements SHIP (2) Manufacturing Engineering Create Process Design to meet Design Requirements DFMEA (3) Process FMEA Evaluates how the Manufacturing / Assembly Process may fail to produce parts / assemblies that meet the Design Intent Outputs from PFMEA include Process Key Characteristics, Risk Profile, Required Prevention and Detection Controls and Improvement actions Process Instructions & Control Plan Key Process Characteristics List Risk Profile In planning the proposed manufacturing process to make the part or assembly the Manufacturing Engineering Team will create a proposed process flow diagram and define how and where the design characteristics will be made and inspected. This information is captured on two key documents (a) The Process Flow Map and (b) The Characteristics Matrix (or Assembly Instructions for Assembly Operations). These documents are key to creating the Process FMEA. The steps for creating a Process FMEA are included in the following chapters. The output of the Process FMEA is a risk profile of all of the Potential Causes of Potential Failure Modes. 14

15 Where the risk is deemed to be unacceptable by the team then they must not proceed until improvement actions are identified and implemented. The other use of the risk profile is to identify the appropriate level of control to be used in the manufacturing or assembly process to ensure conformance and ideally to prevent nonconformance from being created. The Prevention Controls identified within the PFMEA are usually captured in Mistake proofing solutions, Operator Instructions, Asset Care Instructions, etc. Detection Controls from the PFMEA are captured in the Control Plan. The Risk Profile is also a way of prioritising ongoing improvement actions. The Process FMEA is a Knowledge Management Hub for all of the things we know about the production process used to produce a particular part number. Figure 6: Typical Control Strategies based upon the PFMEA Risk Profile RPN and Process Control Hierarchy Typical Strategies Mistake Proofing High Severity Features CCF s / KCFs PFMEA RPN SPC Marginal Process Capability CCF s / KCFs Cpk >2 Features High Cpk & low Severity Features Reference Features Control Plan For high severity risks we must always try to design mistake proofing solutions to prevent the possibility of making the non-conformance in the first place (ideal) or at least to mistake proof the detection of the Failure Mode if it does occur. SPC should be used on those important features identified through the Design DFMEA process (CCFs, KCFs, etc.) but also for processes that have marginal or poor capability. The sensitivity of SPC to target set the process and to detect changes in process stability will be required to optimise the process and prevent it from making non-conformance. 15

16 For processes where we have established a high level of capability (in excess of Cpk of 2) then pre-control limits may be all that is required. Pre-control limits are not as sensitive as SPC Control Charts and are not based on the voice of the process but simply derived from the engineering specification. There may be some features where the PFMEA has concluded that the risk / severity of any non-conformance is so low that it only requires periodic checking e.g. access apertures with open tolerances. This control may be achieved through FAIR and Product Audit activities. Other activities resulting from the PFMEA analysis will be captured in work or Process Instructions e.g. asset care requirements, operator care points, etc. 16

17 The Control Plan The Control Plan is a summary of all of the required Product checks and Process checks required during the manufacturing stage to ensure that the part / assembly is conforming to the design intent. It is designed to be a key reference for the Operator within the process on what is required and is used alongside the Work Instructions / Process Instructions. It will include; What checks are required (of the product or process) The specification of the characteristic being measured How the check is to be done (equipment / visual) When the check is to be done (every part / sample frequency) How the result is to be recorded and analysed (batch card / SPC chart / etc.) What actions are required if the result is not within the specified limits (reaction plan) Each production station should have the relevant part of the Control Plan available for review along with the Operator / Process Instructions. Figure 7: Standard Control Plan Template 17

18 Measurement Systems Analysis Once we have established the product and process inspections required via the Control Plan we must then ensure that the proposed checking method is capable. For variable measurements we use Gauge Repeatability and Reproducibility (GR&R) (as a minimum) and for visual or attribute inspections we use Attribute Agreement Analysis (AAA). Figure 8: Sources of Measurement Error BIAS Same gauge Same feature same operator 30 times Measurement system value Reference value Reproduceability Repeatability Where different CMMs can be used this should be treated as if they were different operators A B C Same gauge Same feature On 3 parts With 3 operators (A, B, & C) Each part measured 10 times each Gauge Repeatability & Reproduceability These capability exercises must be validated using the actual part number and not read across from other similar parts or artefacts. There can be subtle influence of part geometry that can influence the result and will help inform us of the actual measurement capability. These studies must be representative of real production conditions (environment, cycle time, sample of various operators, etc.). The aim is to capture all of the variation present and not to simply pass a test. One common mistake is for the study to be done in controlled conditions so that the typical sources of variation are minimised (best operators, no cycle time pressures, etc.). This will invalidate the result of the analysis. Gauge R&R results should be used to reduce the manufacturing tolerances to take account of the measurement uncertainty. E.g. if we have a Gauge R&R result of 20% then the Engineering tolerance for the feature being measured should be reduced by 20%. 18

19 This process reduction is described in the AIAG Measurement Systems Analysis Manual and in ISO :2013 Geometrical product specifications (GPS) - Inspection by measurement of work pieces and measuring equipment - Part 1: Decision rules for proving conformity or nonconformity with specifications. Figure 9: The Effect of Gauge R&R Result on the Engineering Tolerance in manufacturing The Zone of Uncertainty Zone of Uncertainty USL Useable Tolerance Target Zone Target Zone Nominal Zone of Uncertainty LSL Any reading inside of the specification and the Zone of Uncertainty is definitely a good part (yellow zone). Any measurement outside of specification and the Zone of Uncertainty is definitely a bad part. The Zone of Uncertainty implies that any measurement that is just inside tolerance in this zone may actually be non-conforming but the gauge error has mistakenly measured it as a good part. A reading that is just outside tolerance but in the Zone of Uncertainty may be good but the measurement error has called it bad. 19

20 Initial Capability & Process Control Once we know what to inspect and have established that the inspection method is capable we can begin to collect data from production parts to establish the capability of the process. This can be done for variable measurement characteristics using Cpk and for attribute characteristics using Defects per Millions Opportunities (DPMO). Sample sizes in an Aerospace environment can often be a problem to make statistical analysis meaningful but there are ways in which we can use data from our production parts. For example we can use short run SPC charts to establish the average error on a range of features to give an indication of Cpk. Also some tools will manufacture a number of identical features on a part that we can take measurements from to create a bigger data set. In production we must ensure that our processes are ON TARGET (within the central third of the tolerance) and that change in process setting and trends are identified before they produce non-conforming parts. This will have a big bearing on how process inspection plans are derived. In a Zero Defects environment we must be striving to establish process capability in excess of a Cpk of 2 (six sigma). Figure 10: Processes On Target with Minimum variation TARGET Six sigma Four sigma Two sigma Lower specification Upper specification MINIMUM VARIATION 20

21 Figure 11: Calculating Cpk for a Process Calculate Cpk Cpk = min (X LSL, USL X) 3 3 By centering the process without reducing variability, Cpk could be improved to a maximum of 1.33 (Cp) Further improvements require reduction in process variability The goal is Cpk >_ 2 Below Specification LSL = 48 USL = 60 _ X = 57 Above Specification Standard Deviation = 1.5 For complex products, with many features the impact of Cpk for each feature is high. Figure 12 shows how the Parts per Million (PPM) or Right First Time % (RFT%) is impacted by Cpks of 1.33, 1.67 and 2. In automotive industry the minimum standard for acceptable Cpks is now 2. Figure 12: Impact of Cpk per feature on Part Right First Time & Parts per Million (PPM) Cpk = 1.33 Compressor Blade 50 features 69% PPM = 310,500 Turbine Disk 500 features 0% PPM = 3,200,00 HP / IP 1000 features 0% PPM = 6,400,00 Cpk = 1.67 PPM = 11,650 98% 88% PPM = 116,500 76% PPM = 233,000 Cpk = 2 PPM = % PPM = % PPM = % 21

22 Figure 13 shows a more thorough comparison of the link between Cpk values and PPM. Important to note is the far right hand side column. This shows what the Parts per Million defects would be if the process was allowed to vary by plus or minus 1.5 standard deviations from the nominal value (central third of the control limits). This is a more realistic calculation as most processes will vary around the nominal to some degree during production. Figure 13: Relationship between Cpk, 6 Sigma and Parts per Million 22

23 Chapter Two Process FMEAs Key Points & Care Points Of all of the Defect Prevention tools available to us this is by far the most effective, if applied properly. At a high level the purpose of the Process FMEA is to answer the question what could go wrong in the process that could cause the product to fail to meet the design intent (specification). Once the risks are identified improvement actions can be defined to eliminate or reduce the likelihood of occurrence of the potential cause and/or improve the ability to detect the non-conformance before it is shipped to the customer. Cross Functional Team Approach A Process FMEA is a highly detailed assessment and needs to be conducted by a cross functional team including Manufacturing Engineering, Operations, Quality, Design, Supplier(s) (if appropriate), Maintenance, as a minimum. The team must have the right experience and knowledge of the product and process to add value to the PFMEA. PFMEA Scope For a Process FMEA to be effective it must evaluate ALL the features / characteristics on the design drawing and related specifications and consider every process step (where the product is transformed or has the potential to be transformed including inadvertently such as damage due to storage & handling. A Process FMEA is required for every individual part number. A common mistake to reduce the time taken to complete a PFMEA is to select only those features or process steps where it is believed that are important to the design. There are numerous examples where this pre-selection of what is important has failed to take into account something that has gone on to have a significant impact to the customer. The PFMEA is a tool that is supposed to evaluate all process steps and all product features in order to identify where the risks in the process are. 23

24 Therefore if we do not consider all design features and process steps then the risk assessment will always be deficient. This may appear to be a daunting task, particularly for those organisations that are new to PFMEA. However through the use of computer software and a structure of Reference FMEAs the time taken to create a Process FMEA can be greatly reduced and still remain effective. This approach is described in Chapter s Three and Four. The following notes are a guide of what to look for to ensure that the Process FMEA has been conducted effectively. Figure 14 shows a part completed Process FMEA for a machining operation that is required to drill four holes to a given location and depth. Figure 14: Process FMEA example (truncated) Key Contact / Part Number : ABC123XYZ A. Day (Man. Engineering) Date (Orig.) Phone Description : Block Manifold Process Failure Mode and Effects Analysis (PFMEA) Core Team E. Zee (Engineering), G. Knight (Operations), B. Wright (Quality), I. Care (Maintenance) Customer Approval Date Operation Step Function Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN 10 1 CNC machining Mazak Drill four 10 mm +/- 0.1 mm holes at location 100,30 100, , 50 and 100, 60 (location tolerance +/- 0.2mm) to a depth of 20 mm +/- 1 mm Hole too big Part may vibrate during operation leading to bracket fatigue and system failure Part would need to be scrapped if found during manufacture 9 6 KCF Wrong drill used Drill is oversize from tooling supplier CNC spindle alignment out of specification Tooling set up process Certificate of Conformance only Tooling set up process Weekly Ball Bar check Quarterly laser alignment check CMM check at end of process (OP220) Unable to fit to bracket 4 Tool wear Tooling set up process Hole too small Wrong drill used Tooling set up process CMM check at 2 end of process (OP220) Marginal fit causing stress to bolt. 8 Drill undersize from tooling supplier Tooling set up process Certificate of Conformance from supplier It is vital that the descriptions included within the PFMEA are detailed enough to be understood by engineers who were not directly involved in the creation of the document. 24

25 These documents will be in use for many years and it is important that they can be reviewed by teams in the future that understand the intent of what has been written. The precision of the use of language in a PFMEA are paramount. How to complete a Process FMEA using the AS13004 PFMEA template: a) Part Number & Description The requirement is to include the full Part Number and a brief description of the part. The description should include the Model / Engine Name e.g. Trent 1000 and a brief name of the part e.g. Fan Blade, HP Compressor Blade, etc. The Process FMEA should be specific to an individual part number or assembly. Rarely will it be appropriate for a single Process FMEA to cover more than one part number / assembly. Non part number specific PFMEAs should be discouraged. Some reasons often cited for the use of PFMEAs that are not part specific are; Generic Processes It is often thought that processes such as Heat Treatment or Cleaning are exempt from the specific Part Number approach of a PFMEA. In reality there are very few examples where the impact of the process is not part specific and therefore it is recommended that these processes are considered in the same way as a machining process and unique to each part number that goes through it. Just as with other processes such as machining, the consequences of a process failure are likely to be specific to the part number specific application. Part Families It is often proposed that many parts can be included as a part family approach to a Process FMEA. This will work if the part is identical with the same functional requirements, same consequences of failure, operating in the same conditions, with the same features, same specification tolerances, etc. Otherwise it is not closely related enough to simply read across. Part families are normally defined (in the automotive industry) as a part that is exactly the same as another except for some additional features. 25

26 For example a Cylinder Head used on a V8 5V engine is also used on a high powered derivative. In the derivative the cylinder bores are honed to a tighter specification but all other features remain the same. This is an example where the Family of Parts approach can be taken and the additional PFMEA analysis needs only to be completed for the modified cylinder bores. In this example due to the tighter tolerancing we would expect to see higher Occurrence scores. There are some applications where FMEAs can be used in non-part specific applications. For example there are Machinery FMEAs that help with the design of process equipment or fixtures. Some Service Sector businesses use an FMEA approach to help them design transactional processes. These approaches are out of scope for this Guidance document. 26

27 b) Core Team The requirement is to list the core team members and their positions that were responsible for the original document. We should remember that this document will be regularly updated for the life of the part and therefore the team members will change over time. It is important that the team is comprised of the right resources to be able to identify and assess potential product Failure Modes and Potential Process Causes. As a minimum it would be expected to include Manufacturing Engineering, Design Engineering, Operations, Quality and Maintenance. It may also be appropriate for a Customer and/or a relevant Supplier representative to be involved at certain stages of compilation or review to capture their insights. Not all members of the team need to be present for all stages of creating the FMEA as their input may be limited to specific aspects e.g. The Design Engineer has input into the effect and severity of the identified Product Failure Modes but may not have knowledge of the process to add any real value. When compiling Reference PFMEAs a small core team should be assembled of 3 4 people with the correct knowledge of the part and process being considered. Too many team members will only serve to slow the process down and will have little added value. Figure 15: Team Size Effectiveness Effectiveness %s Team Size Once completed, the Reference PFMEA and the Part Specific PFMEA can be circulated to a wider group for additional input and sanity checking. 27

28 c) Original date / Revision date The Process FMEA will be a live document and as such revision control is vital to provide a traceable history of updates etc. Revisions to a Process FMEA will be expected if any of the following occur; Product definition changes Process changes (including inspection processes) Updates from 8D investigations / Continuous Improvement actions Quality Performance data that may influence the RPN scores 28

29 d) Operation / Step The Process FMEA must include all process steps where the product is transformed even where the transformation may be inadvertent, such as during handling and storage. The Process FMEA must include all steps from the first operation through to dispatch. Care must be taken not to fall into the trap of only completing the PFMEA on processes that are seen to be important. The Process Steps should be defined on a Process Flow Diagram that shows the sequence of operations and the purpose (required outcomes) of each operation. A Characteristics Matrix should define the features that are created and inspected at each operation. Some common mistakes observed are; Transactional processes are included e.g. complete batch card, load CNC program. These in themselves are not relevant to the Process FMEA although they may appear as a Potential Cause of a failure if a link can be made. Similarly, processes such as Load Tools into CNC similarly do not belong in a PFMEA as a process step. There can be no product Failure Modes created at this process step as it is not used to transform the product. If the loading of tools has any impact on product quality then this will be recorded as a Potential Cause of a defined Failure Mode in the PFMEA in a later process step. Measurement processes are included as a process step and seen as the cause of dimensional non-conformance. It should be remembered that the Measurement System is considered at each process step as part of Detection Method and does not need to be considered independently. The only relevant consideration is if the part can be damaged during the act of measurement through handling or storage. 29

30 e) Process Function / Requirement For each Operation the function (purpose) and the required outcome (Requirement) should be defined. This must be written in enough detail so that the Potential Failure Mode (next column) can be derived straight from the description. For example, if the purpose at this step (or one of its purposes) is to drill a hole 10mm +/- 0.2 mm, then the potential ways in which we could fail to achieve this is simply Hole too Big i.e. above 10.20mm or Hole too Small, i.e. less than 9.80 mm. In an assembly operation the requirement may be to fit a seal, in the correct orientation, without damage or contamination to the sealing faces. The potential failure modes would then be (a) incorrect orientation, (b) surface damaged and (c) surface contaminated. At this step it is important to identify all of the requirements that help to define a feature as conforming or non-conforming. For example many features will have a general specification associated to it that is not necessarily apparent on first glance. A drilled hole feature will have geometric tolerances but also may be subject to an Engineering Specification that specifies no white layer or similar. All requirements whether on the drawing or written in a related specification must be included. Dealing with Manufacturing Tolerances The PFMEA must include Manufacturing Tolerances that are used to manufacture of the part. Ideally these Manufacturing Tolerances will be identified in some way within the PFMEA to make it clear what is an Engineering requirement and what is a Manufacturing one (e.g. a designated symbol in the characteristics column or other means). Manufacturing tolerances can also refer to processes required for a successful manufacturing step. For example a cleaning operation may be included prior to welding to ensure there is no contamination that could cause porosity. Although this may not be specified in the drawing or specifications there is an internal requirement to ensure the part is clean prior to welding. Therefore at the cleaning operation it is allowable to include clean part as a process requirement (the cleaning process may also be referenced as a potential cause of porosity defects when evaluating the welding process). 30

31 Figure 16: Process Function and link to Potential Failure Modes in a PFMEA Key Contact / Part Number : ABC123XYZ A. Day (Man. Engineering) Date (Orig.) Phone Description : Block Manifold Process Failure Mode and Effects Analysis (PFMEA) Core Team E. Zee (Engineering), G. Knight (Operations), B. Wright (Quality), I. Care (Maintenance) Customer Approval Date Operation Step Function Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN 10 1 CNC machining Mazak Drill four 10 mm +/- 0.1 mm holes at location 100,30 100, , 50 and 100, 60 (location tolerance +/- 0.2mm) Hole too big Part may vibrate during operation leading to bracket fatigue and system failure 9 KCF Wrong drill used Drill is oversize from tooling supplier Tooling set up process Certificate of Conformance only Tooling set up process Weekly Ball Bar check CMM check at end of process (OP220) 7 to a depth of 20 mm +/- 1 mm Part would need to be scrapped if found during manufacture 6 CNC spindle alignment out of specification Quarterly laser alignment check Unable to fit to bracket 4 Tool wear Tooling set up process Hole too small Wrong drill used Tooling set up process CMM check at 2 end of process (OP220) Marginal fit causing stress to bolt. 8 Drill undersize from tooling supplier Tooling set up process Certificate of Conformance from supplier In this example we can see that the Potential Failure Mode is a logical step from the way in which the requirement was described. This is particularly important for assembly operations where the level of detail required may not be so obvious. For example when fitting two parts together the characteristics of success are not so explicit on the drawing or design notes. Therefore the Process FMEA (and later the Process Instructions) must provide the detail required. For example; Fit Part A to Part B in the correct orientation without causing any damage to surface D and fix with a single threaded bolt and nut to a torque value of 100N +/- 2 N and an angle of 360 degrees. 31

32 Hence from this description the following Failure Modes could be derived; Incorrect orientation Damage to surface D Torque too high Torque too low No torque Bolt not fitted Angle not achieved We must take care not to infer requirements that are not there. There are examples where the requirement was for a drilled hole at 10mm +/- 0.2 mm and the team went on to list other Failure Modes such as hole not round. Unless there is a specific roundness specification called out on the drawing then this is not relevant and should not be included. There may also be some general drawing specification requirements that need to be considered at certain operations. These include such things as; No Damage / Damage not to exceed specified limits No Sharp edges / burrs No Foreign Object Debris (FOD) / No FOD above specified limits If appropriate to the operation these should be considered as additional requirements of the operation and hence will have associated Potential Failure Modes. 32

33 f) Potential Failure Modes As described in the previous section the Potential Failure Mode is the way in which the product could fail to meet the design intent (drawing or specification). It is critical that the Potential Failure Mode describes a product feature / characteristic and not a process failure. If this column is not completed correctly all of the subsequent work in the FMEA columns to the right of this one will be irrelevant. A simple question to ask is does the Potential Failure Mode describe something on the product that is not right to the drawing or specification? There are likely to be several Potential Failure Modes per feature / characteristic. This is another good way to check if sufficient rigour has been applied to the PFMEA, if there are only single Failure Modes identified then something is likely to be wrong. Care should be taken not to simply list degrees of error though. For example hole too small is often adequate to describe a Failure Mode and its consequences. Avoid using hole just undersize along with hole 10% undersize, and hole twice tolerance undersize, etc. If there is a series of consequences due to hole too small then this should be captured in the Potential Effects column (See example PFMEA). Table 1 : Failure Mode Examples Valid Failure Mode Description Hole too big Surface finish too rough Torque applied above specification Profile shape incorrect Missing feature Porosity in weld material Hole out of position Invalid Process Failure Mode Descriptions Drill broken Machine failure Wrong torque setting used Scrap parts Wrong CNC program used Damaged tooling Incorrect coolant pressure Another good sanity check at this stage is to review the identified Failure Modes against known non-conformance on similar parts e.g. customer escapes, scrap causes, rework causes, etc. Have all of these Failure Modes been captured? 33

34 g) Potential Effect of Failure This is a key point where the link to the Design FMEA and Design Engineering has an important role to play. Every feature will have a design purpose, otherwise why would it be there? Therefore if the feature was not present or was nonconforming we must understand the impact that will have on the final product (as seen by the customer or end user) as well as the impact on the manufacturing plant / business. This is one of the factors that help to explain why process based (generic) PFMEAs as opposed to product focused PFMEAs are not effective. In a process based PFMEA the risk would be assumed to be equal for all holes drilled during that operation and hence scored identically. The different purposes of each hole means that the effect and hence the impact for each hole may be different. This would not be identified unless the PFMEA focuses on the Product Features. Using the process based PFMEAs also means that the link to the Design FMEA is irrelevant. All relevant effects should be listed for each Potential Failure Mode. We would expect to see multiple effects for most potential Failure Modes (another good check to make). The most important effects to highlight are those that will be experienced by the customer or end user, particularly if there are safety implications. Internal effects can also be listed e.g. scrap, rework and for certain product Failure Modes where there may be a significant safety impact to the operator, these should be included too (see Severity Scoring guidelines). Providing the Right Level of Detail for the Potential Effects Description When describing the Potential Effects of Failure it will be important to understand the conditions that need to be present for the Effect to be realised. E.g. If a dimensional defect may have a range of potential effects depending upon the scale of the non-conformance. This means that the defect may sometimes be cleared on a concession, reworked or scrapped. But to say this is not enough, we need to explain when it is ok to concess it or scrap it. So for this type of Failure Mode we would expect to see three types of effect description; 1. If the defect is oversize then it may be possible to rework the dimension and bring it inside the specified tolerance 2. If the dimension is marginally out of the bottom of tolerance and therefore cannot be reworked then Design may be able to grant a concession.to allow the product to proceed 3. If the part cannot be reworked or concessed then the part will be rejected (scrapped) 34

35 There may be times where a Failure Mode in one process could cause a different Failure Mode later in the process. For example, contaminated part is a Failure Mode for a cleaning process and one Effect of Failure could be Porosity in weld at a later operation. In this example the team must be as specific as possible in the description of the Effect. NOTE : Operator safety impacts should only be considered if they are resulting from a product failure not a process one, and then only if it meets the criteria specified in the Severity Scoring table i.e. not for minor HSE issues. Process Risk assessments are a separate activity. h) Severity Rating The severity of each potential effect of failure is made using the scoring table in AS13004, and shown below in Table 2. When calculating the Risk Priority Number (RPN) later on the highest (most severe) score will be used for this Potential Failure Mode. Sometimes this is not always possible to do straight from the DFMEA and therefore the presence of the Design Engineering representative is crucial to both identify the potential effects and score the severity. In the same way, even if there is no DFMEA available, having the right Design input can enable an effective Process FMEA to be created. Table 2 : AS13004 Process FMEA Severity Risk Scoring 35

36 i) Potential Cause(s) of the Failure Mode In this section we are looking to identify the things in the manufacturing / assembly process that could cause the Potential Failure Mode to exist. This is the reason it is referred to as a Process Failure Mode & Effects Analysis i.e. we are looking for the Process Risks of producing product non-conformance. We would expect to see multiple Potential Causes per Failure Mode if done properly. Figure 17: Potential Causes of Failure in a PFMEA Key Contact / Part Number : ABC123XYZ A. Day (Man. Engineering) Date (Orig.) Phone Description : Block Manifold Process Failure Mode and Effects Analysis (PFMEA) Core Team E. Zee (Engineering), G. Knight (Operations), B. Wright (Quality), I. Care (Maintenance) Customer Approval Date Operation Step Function Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN 10 1 CNC machining Mazak Drill four 10 mm +/- 0.1 mm holes at location 100,30 100, , 50 and 100, 60 (location tolerance +/- 0.2mm) to a depth of 20 mm +/- 1 mm Hole too big Part may vibrate during operation leading to bracket fatigue and system failure Part would need to be scrapped if found during manufacture 9 6 KCF Wrong drill used Drill is oversize from tooling supplier CNC spindle alignment out of specification Tooling set up process Certificate of Conformance only Tooling set up process Weekly Ball Bar check Quarterly laser alignment check CMM check at end of process (OP220) Unable to fit to bracket 4 Tool wear Tooling set up process Hole too small Wrong drill used Tooling set up process CMM check at 2 end of process (OP220) Marginal fit causing stress to bolt. 8 Drill undersize from tooling supplier Tooling set up process Certificate of Conformance from supplier The key success factor here is to produce a list of Potential Causes that are controllable in other words where there is a direct cause and effect. Good examples are incorrect drill used oversize or spindle alignment not true. In other words if these things were to happen then the outcome would almost certainly result in non-conforming product. These examples allow us to take a specific action to control them. 36

37 Common problems here are where the team has identified a long list of Potential Causes that are quite tenuous. For example operator incorrectly follows procedure, maintenance error. These descriptions are of no value in creating an effective Process FMEA and the required actions will be difficult to define. The team should assume that the incoming parts / materials are correct. The team may make exceptions to this but only where the historical data suggests that this is a known problem. Dangers of too much detail! However we should also avoid going into unnecessary detail too. In an example where the location of a weld could be misplaced the team identified that one of the Potential Causes could be that the part was incorrectly located in the fixture. This is true. The team went on to list all of the reasons why the part may be incorrectly loaded in the fixture e.g. operator error, fixture worn, fixture damaged, etc. This additional detail adds no further value to the PFMEA than part incorrectly located in fixture. Great care must be taken to avoid unnecessary detail that will prevent us from seeing the wood for the trees. Teams can often over think this section of the PFMEA. The use of Fishbone diagrams to create long lists of Potential Causes by brainstorming machine, method, environment, manpower, maintenance, etc. is not usually required. The knowledge of the process is usually well understood by the Manufacturing Engineer, Maintenance Engineer and Operator (for example). Using the logic from the PFMEA template it is more usual that a simple list can be created easily from this combined knowledge. The list should be evaluated for opportunities to group similar causes together or to challenge if the potential cause is really linked to the Failure Mode. 37

38 j) Prevention Controls For each Potential Cause identified we now need to identify what controls we have in place (or not) to ensure that the Potential Cause cannot happen. The best form of Prevention Control is Mistake proofing e.g. Fixtures that prevent the part being loaded incorrectly. For high severity features we must strive for this type of control. There are some controls, whilst not mistake proofing, do offer some protection of preventing the potential cause from happening e.g. Calibration, Maintenance routines, etc. For example : Using our PFMEA example we can see that one of the Potential Causes for hole oversize is spindle alignment out of specification. In this case the business has recognised this issue and introduced a Maintenance Schedule to check for spindle alignment using two methods; a) a weekly ball bar check completed by the operator and b) a quarterly laser alignment check conducted by the Maintenance Team. Provided that these two activities are done to schedule and any actions identified through the checking process are addressed then we would expect to see very few oversize hole conditions caused by spindle alignment error. Another example would be tool oversize wrong tool used, it may be logical to include checked by operator during set up but this can only be included if it is clearly demonstrated that the set up checks really would find this error e.g. one of the set up checks requires a bar code reading of the tool in each tool holder. If it is not specific and is just down to luck then it should not be included. Unnacceptable Prevention Controls Another example to be careful of is the use of Operator Training as a Prevention Control. Is this really going to prevent a potential cause from happening? The danger is that having put this comment in the box the team move on without really questioning what better controls could we have. If the only control was Operator Training then we should be wary of its effectiveness and it may be better not to include it at all. If there are no current Prevention Controls for this specific potential cause then be prepared to write none in this column. It may be that addressing this gap will become one of the improvement actions. CARE POINT : The controls we identify must be things that can genuinely prevent the cause from happening not just reduce the likelihood of occurrence. They will be activities that stop the cause from happening not find it afterwards. A common mistake is to list things in here that detect the Potential Cause rather than prevent it. For instance a tooling check at the end of the process to ensure that it is not broken is not a Prevention Control but a Detection Control. 38

39 k) Occurrence Rating The occurrence rating looks to evaluate the potential for the Potential Cause of Failure to occur. Again, as for the Severity Rating, this is done on a scale of 1 to 10 where 10 is will happen nearly always and 1 is will never / unlikely to happen. Each Potential Cause identified needs to be rated separately. Typical data sources include: customer escapes, process capability performance data (Cp, Cpk), Parts per Million (PPM), warranty metrics, etc. Important Care Point when scoring Occurrence Ratings The ability to be able to rate the occurrence individual Potential Causes will depend upon the data captured by the company. In many cases this may not be available for individual causes and so there are a couple of options on how to score Occurrence. 1. Use the same score for each Potential Cause. i.e. if we know that hole over size occurs at around 500 parts per million (1 in 2000), this would score a 4 in our Occurrence Rating table. We could use the same score for all of the identified Causes. The downsize of this approach is that it overestimates the occurrence of this cause and treats them all the same, but if we have no better information it may be the easiest way to begin until further data is available. If we have some experience of the main causes we can use our engineering judgement to share the score among each Cause. For example, the three elements should add up to the same total (1 in 200) but our judgement may be that spindle alignment is most likely with wrong drill used or drill oversize being very remote (may not have ever noticed this before). We may allocate a score of 4 to spindle alignment and a score of 2 or 3 to the other two Potential Causes. As we can see this is not an exact science but we need to ensure that we do not under call individual causes and therefore avoid taking any actions later. 39

40 Table 3 : AS13004 Occurrence Rating Table for Process FMEA 40

41 l) Detection Controls This is a description of all of the ways in which the Potential Failure Mode (and key Potential Causes) are checked or inspected for conformity throughout the process. Typically it will take the form of in process checks by the operator, automated controls or mistake proofing, or formal inspection routines. The team should document all of the applicable controls in place and score each one using the Detection Scoring Table. As we know that each Potential Cause will have its own RPN value it is important to recognise that each Detection Control must therefore be aligned to each Potential Cause. For example, if we inspect hole diameters using a co-ordinate measuring machine at the end of the line then this detection method would score 7 in our Detection Rating chart (see Table 4). This score would be read across to all Potential Causes for against each Failure Mode identified for Hole Drilling. If there are any other detection methods used for certain Potential Causes then these should be listed against that particular Potential Cause and scored appropriately. See PFMEA RPN Scoring Worked Example for further details. 41

42 m) Detection Ranking The team will evaluate each of the Detection Controls identified in the previous column using the criteria contained within the Detection Scoring Table. The question they must answer is If the Potential Failure Mode did occur how likely is it that we would be able to detect it before it was despatched to the Customer? The focus of the ranking is on the methods deployed to inspect or prevent the Failure Mode and the stage of the process where the inspection is conducted i.e. at the point the Failure Mode could be created or later on in the process. Particular points to note on this rating table are; There is no reference to the capability of the gauging method. It assumes that whatever gauging method or inspection process is used that is has been proven capable. The only way to score lower than a 5 on the scale is to employ automated controls to detect the Failure Mode (rank 2 to 4) or an automated control to prevent the Failure Mode Potential Cause (rank score of 1). Table 4 : AS13004 Detection Rating Table 42

43 n) Risk Priority Score The next stage of the Process FMEA is to calculate the Risk Priority Number (RPN) for each Potential Cause of a particular Failure Mode. The calculation is quite simple. Severity x Occurrence x Detection = RPN The Severity Score we use is the highest ranked number for the Failure Mode, i.e. the worst that could happen. The Occurrence Score for each Potential Failure Mode is used i.e. there will be an RPN score for every Potential Cause identified for a particular Failure Mode. The Detection Score is the best (lowest) score identified. This means that, provided that all parts go through each inspection point, the most effective detection activity will catch the Potential Failure Mode before it is shipped to the customer. Figure 18: RPN Scoring Example Failure Mode Effects Severity Potential Causes Prevention Controls Occurrence Detection Control Detection RPN Figure 18 shows that to calculate the RPN for the Failure Mode we select; 1. The HIGHEST Severity score, multiplied by, 2. EACH Potential Cause Occurrence Score, then multiply by 3. The LOWEST Detection score for each related to each Failure Mode and Potential Cause (if relevant). 43

44 Therefore there are three RPNs, one for every Potential Cause. It can often be worth doing a quick sanity check by calculating the overall RPN for a Failure Mode. 1. It is easy for us to identify the Severity Score for a particular Failure Mode so we should use that. 2. The Occurrence Score for an individual Cause can be quite difficult to get but the overall failure rate for the Failure Mode should be relatively easy so we can use that. 3. The Detection Score, especially that associated with Inspection, is also quite easy to get hold of so we can use that. Calculating these three scores will give us an approximation of the Risk profile for that Failure Mode that we can then compare to our individual RPNs for each Potential Cause. We can then adjust the Occurrence Scoring if required for the individual scores if necessary. 44

45 o) Improvement Actions For all of the rigour of a Process FMEA, if done well, if we do not then react to the risk profile then it is of no value. The key focus must be on those risks that scored high for severity, regardless of the other scores. What further action do we need to take to reduce the RPN of these items through, ideally, improving the prevention of the Failure Mode, or if not, improving the Detection of the Failure Mode. Remember the only way to reduce the Severity score is usually to redesign the product. High RPNs do need to be addressed. There is no set way of doing this. There is a judgement required. How much risk are you prepared to tolerate? Some RPNs will stand out using the pareto principle as being excessive and will clearly need to be improved. Some companies use a RPN threshold value to select which RPNs they are going to improve. This can be dangerous as teams soon learn how to get a score that falls below the threshold value (it is not an exact science after all). Another strategy is to look at the profile and see where the data suggests a levelling out of RPNs. The risks to the left of this point should be considered for improvement. Remember the continual reduction of the overall risk should be our aim this is an ongoing process that never stops. Improvement actions should be documented in the PFMEA and once implemented and verified the RPN can be recalculated to measure the effect of the improvement action. 45

46 Figure 19: RPN Improvement Actions in a PFMEA 46

47 PFMEA RPN Scoring Worked Example Let s assume that the Failure Mode is hole diameter too big. The team have identified four potential effects; 1. Minor deviations may need to be concessed, minor operational disruption, customer would not notice = Severity Score of Could cause sub system vibration impacting product performance noticed by the customer = Severity Score of Could cause vibration in engine leading to premature wear and potential product failure (not safety related) = Severity Score of Could cause vibration noise that would be noticeable to customer = Severity Score of 5. Therefore in this example the Severity score used will be the highest, which is 8. The team has identified three Potential Failure Causes; 5. Wrong Drill used (oversized). There is no defined Prevention Control for this potential cause. 6. Spindle wear on CNC Machine. The business has two ways of preventing this potential cause (a) weekly ball bar checks conducted weekly by the operator and (b) laser alignment checks conducted by the maintenance function every 6 months. 7. Damaged tool (drill). The machine has a built in program that uses a vision comparator system for each tool before it is used to check for damage. There will be an Occurrence score for each Potential Cause identified. Occurrence Scoring The team know that this is a problematic feature with a tight tolerance. It causes around 15% of non-conforming parts, most of which are concessed (minor deviation). The team do not have data to show how this non-conformance can be accurately attributed to each of the three causes so they have decided on the following logic. 1. Most likely reason is spindle condition. The data shows a wide spread of results and a Cp of less than 1 which could be due to the machine inaccuracy. They have assigned the score of 7 indicating that this cause accounts for at least half of the problem. 2. The team knows that incorrect tooling used has happened before, although infrequently (once or twice per year), and as there is no prevention activity for this potential cause they have put a score of 4. 47

48 3. The tooling vision system has prevented broken tools from being used since its implementation over 9 months ago. They decided to score it as a 2 rather than a 1 as it is still relatively new. Detection Methods and Scoring The hole diameter is measured using a variable gauge in process by the operator, that would be a score of 5 for Detection. For the three Potential Causes this Detection Score will be shown against each as a starting point. The Detection Methods for both Wrong Tool Used (oversize) and Spindle Wear rely on the Operator inspection of the Failure Mode, in-station using a bore micrometer. Therefore these have both been scored a 5 using the Detection Scoring Guidelines. The Potential Cause for Damaged Tool can be detected automatically using the vision system built into the CNC machine. The team have used the same logic as for Occurrence scoring and assigned this a Detection Score of 2. Calculating the RPN Therefore in our worked example the three RPN Scores (one for each Potential Cause) would be; Potential Cause 1: Wrong Drill Used (oversize) Severity 8 x Occurrence Score of 4 x Detection of 5 = 160 Potential Cause 2: Spindle wear Severity 8 x Occurrence Score of 7 x Detection of 5 = 280 Potential Cause 3: Damaged Tooling Severity 8 x Occurrence Score of 2 x Detection of 2 = 32 48

49 Why use the lowest Detection Score? The selection of the lowest Detection Score rather than the highest can often cause some confusion. Think of it as if each Detection Control is like a filter paper of different grade (1 to 10). If you have three detection methods scored at 2, 6 and 8 then if the Failure Mode was to try to pass through them (in series) then the one scored at 2 would be the most effective and hence that is the score we would use. See Figure 20. Figure 20: Detection Scoring Analogy Failure Modes Detection Filters (scores) Filter Size 8 Filter Size 6 Filter Size 2 Once the RPNs for each Failure Mode and Potential Cause have been calculated they can be ranked in order of RPN Score (Pareto principle). Being able to see the Risk profile of the complete process is useful for us to be able to identify those process steps with the highest risk however such as a simple analysis is not enough to determine what actions should be taken. 49

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51 Chapter Three Creating Reference Process FMEAs Reference Process FMEAs should be developed by a cross functional team comprising of Manufacturing Engineers, Design Engineers, Maintenance, and Operations. Ideally, Reference PFMEAs should be kept at a company level and maintained by the accountable Manufacturing Process Owner. They should be used across the business to create part specific PFMEAs in the most efficient manner. Reference PFMEAs are not simply a cut and paste solution. They are simply using the knowledge from similar features and processes, that once created, are relevant for multiple features included in the Part Specific PFMEA. The figure below shows what can be included within a Reference PFMEA and why. Figure 21: Overview of Reference PFMEA Elements Potential Failure Modes Causes will be specific to the type of process / equipment used to create the feature / characteristic Detection Controls describe the inspection in place to identify the Failure Modes and Causes Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN Failure Modes are universal descriptions of the requirement / specification Prevention Controls describe the activities to prevent the Potential Causes from occurring Prevention & Detection Controls tend to be business specific The greyed out columns require part specific information and therefore can only be completed when completing the part specific Process FMEA. 51

52 STEP 1: Select the Process for Evaluation A reference Process FMEA will be specific to a process type e.g. CNC machining, Electron Beam Welding, Torque Fastening, Grit blasting, etc. The team must first select the process type for evaluation. Some processes will have several sub process types. For example CNC machining may have sub process types of; Turning Grinding Milling Drilling The team would focus on one of these elements to create a Reference PFMEA. The Reference PFMEA may also be equipment specific. Some CNC machines will be constructed in a unique way and therefore the Potential Causes of Failure may be unique to that equipment type. The Team will need to decide if the best approach is to create a universal Reference PFMEA or to allow derivative to be developed also. Step 2: Define the typical Features and Characteristics of the Process being evaluated Each Process Type will have the potential to create certain features and characteristics. The team should list these out for the process / sub-process under evaluation. A typical characteristics matrix or Assembly Instruction for the process may help to identify features / characteristics. The team also need to refer to typical drawings and related engineering specifications. For example a drilling process on a CNC machine will create the following features / characteristics; Hole position Hole diameter Hole depth Hole roundness Surface Finish No White layer An E-Beam Welding process will create the following features / characteristics; Weld position Weld length Weld width Weld porosity within limits Weld with splatter within limits 52

53 The Reference PFMEA should be structured in such a way that the team can select specific features from the process / sub-process to be used in the creation of a Part Specific PFMEA. Define all Features / Characteristics before moving onto the next step. Step 3: Define Typical Failure Modes for each Characteristic Design Features and Characteristics will have a universal and finite number of Potential Failure Modes associated with them, irrespective of how they are produced. The team can brainstorm these as a start to helping define the Reference FMEA database. Examples are shown in Table 5 (see also Appendix B). Table 5: Example Failure Modes Characteristic Length Failure Mode(s) Too Long Too Short Diameter Too Big Too Small Radius Too Big Too Small Location Surface Finish Incorrect Location Too rough Too smooth Profile Shape Roundness No scratches / blemishes No pitting Incorrect Profile Out of Round Scratches / Blemishes Pitting 53

54 For each of the Features and Characteristics listed in Step 2 the team must now define the relevant Potential Failure Modes. In addition there may be universal Potential Failure Modes on the Drawing or related Specifications that the team should also consider e.g. Damage, FOD, Surface Finish requirements, cleanliness, etc. that are not directly related to the feature but will be evaluated on the finished part. STEP 4: Identify Potential Causes of Failure by Process Type The Potential Causes of each Failure Mode will depend upon the process that is being used to create the Feature / Characteristic. For example drilling a hole with a diameter of 10mm +/- 1 mm the Failure Modes will be the same i.e. Too Big or Too Small. However the Potential Causes of Hole too Big if created on a CNC will be different to those if created using, for example, laser drilling. Therefore Reference FMEAs now need to become specific to a process type. In this example we shall consider hole drilling on a CNC machine. The team will need to decide if CNC drilling is a single Reference PFMEA or if there are different types of CNC machines that may require their own Reference PFMEA. This can be decided by looking at the list of Potential Causes for each. If they are similar then we should strive to have only one Reference PFMEA if they are significantly different (due to the mechanical nature of the equipment for example) then separate Reference PFMEAs should be created. The team should consider all of the direct causes that could create the Product Failure Mode. 54

55 Figure 22: Reference PFMEA for CNC Hole Drilling: Potential Failure Mode Causes Reference Process Failure Mode and Effects Analysis (PFMEA) by Characteristic Feature / Characteristic Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN Drill Hole Wrong drill used Diameter too big Drill is oversize from tooling supplier Diameter CNC spindle alignment out of specification Tool wear Diameter too small Wrong drill selected Drill undersize from tooling supplier Tool Setting incorrect Too Deep CNC program offset incorrectly set Depth Tool setting incorrect Not deep enough CNC program offset incorrectly set Tool wear 55

56 STEP 5: Identifying the Prevention Controls aligned to the Identified Potential Causes in the Reference PFMEA In the next step the team should identify the Prevention Controls that can prevent the Potential Cause(s) identified. Again great care should be taken to ensure that these Prevention Controls are actually in place and effective. In practice the Prevention Controls may be unique to a particular plant or site and therefore great care must be taken when reviewing the Part Specific PFMEA to confirm that those listed are actual practice and not just recording another businesses best practice. It can be useful however to have a starter list for teams to review and to challenge them on the application of best practice. Figure 23 Reference PFMEA Prevention Controls Failure Mode and Effects Analysis (FMEA) Design / Process Part Number Key Contact / Phone Core Team Date (Orig.) Customer Approval Date Process Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN Recommended Action Resp & Target Date Actions Taken SEV OCC DET RPN Wromg drill used (too big) Drill oversize (from supplier) Tool setting procedure (TS001) confirms tool size Tool setting procedure (TS001) confirms tool size Hole too big CNC Spindle out of alignment Monthly ball bar checks and 6 monthly laser alignment checks included in Asset Care (AC012) CNC Drilling Hole Diameter Swarf pick up in tool Part able to move in fixture Wrong drill used (too small) None Set Up check by operator Tool setting procedure (TS001) confirms tool size Hole Too Small Drill too small (as supplied from supplier) Tool setting procedure (TS001) confirms tool size Tool setting procedure Drill worn (TS001) confirms (too small) tool size and Tool life included in Machine program. 56

57 STEP 6: Identifying the Typical Detection Controls for the Failure Mode in the Reference PFMEA The next task is to identify the typical Detection Controls for the Failure Mode. These will be used as a guide only and should include the latest thinking from the business experts. As with the Prevention Controls these are often plant / site or business specific and will need to be reviewed closely to confirm that they reflect the actual condition for the application under review (the Part Number specific PFMEA). The Global Process Owner may have minimum requirements for certain Detection Controls and these must be adhered to. For example there may be a standard method for measuring surface finish inside a bore that requires specific measuring equipment. Mandated Detection Controls should be identified within the column with a comment. If the part specific PFMEA identifies that the Global Process Owner mandated Detection Controls are not in place then this should be identified as an improvement action within the PFMEA. 57

58 Figure 24: Identifying the Typical Detection Controls in the Reference PFMEA Failure Mode and Effects Analysis (FMEA) Design / Process Part Number Key Contact / Phone Core Team Date (O Custom Approval Process Requirements Potential Failure Mode Potential Effect(s) of Failure Severity Classification Potential Cause(s) of Failure Prevention Controls Occurrence Detection Controls Detection RPN Recomme Actio Wromg drill used (too big) Tool setting procedure (TS001) confirms tool size Drill oversize (from supplier) Tool setting procedure (TS001) confirms tool size Hole too big CNC Spindle out of alignment Monthly ball bar checks and 6 monthly laser alignment checks included in Asset Care (AC012) CMM Inspection at OP240 CNC Drilling Hole Diameter Swarf pick up in tool Part able to move in fixture Wrong drill used (too small) None Set Up check by operator Tool setting procedure (TS001) confirms tool size Hole Too Small Drill too small (as supplied from supplier) Tool setting procedure (TS001) confirms tool size CMM Inspection at OP240 Drill worn (too small) Tool setting procedure (TS001) confirms tool size and Tool life included in Machine program. 58

59 Chapter Four Completing a PFMEA using Reference PFMEAs Building Blocks In a mature state the business will have a database of all of the Reference PFMEAs it requires for the processes that it uses. This database will represent the best practice for each process and be a knowledge management hub recording all of the company s insights into managing the process. The Reference PFMEA database should be updated whenever new information comes to light so that it can be shared across the business forming a key part of the continuous improvement activity. As there is no product specific details held within the Reference PFMEA these can be made available to the external supply chain for them to use. This will also enable the knowledge management database to be updated by the experienced and knowledge held within the external supply chain as well as within the business making the approach even more powerful. Care must be taken when designing the Reference PFMEA file structure to make it easy to access and find the right element. The typical structure will include 4 levels. Level 1 : The Process Group This is the common name for the process and is usually defined by the equipment or process. Examples include CNC Machining, Joining, Surface Preparation Level 2 : Process Type This is where the process can be made more specific and will take the form of the equipment used or more detailed process description. For example CNC Grinding, CNC Drilling, CNC Turning, Joining by E-Beam Welding, Joining by Inertia Welding, Surface preparation by grit blasting, etc. Level 3: Process Description The Process type may need to be made more specific if there are various methods or equipment variation that can impact on the level of commonality of the process causes e.g. CNC grinding on a Mazak CNC may have a different set of Potential causes to that ground on a Viking horizontal grinding machine. In this case there may need to be two separate Reference PFMEAs for CNC Grinding, one for the Mazak and one for the Viking equipment. 59

60 Level 4 : Process Characteristics / Features The Reference PFMEA now needs to identify the typical features / characteristics that the process / equipment is designed to create. E.g. for the CNC grinding operation using the Mazak this could include ; Size (length, height, etc.) Radii Angle Surface finish This structure is shown in Figure 25. Figure 25: Reference PFMEA Database Structure Example STEP 1: Select the Part Number for the PFMEA activity & collate all related documentation required to complete the PFMEA PFMEAs must be completed for a specific part number or assembly. The scope will include all process steps and all features that are created to meet the design intent. In order to create a part specific PFMEA the team will require; 1) Part / Assembly Drawing(s) 2) Related specifications called up on the drawing(s) 3) Process Flow Diagram detailing the method of manufacture 4) Product Characteristic Matrix that specifies the features created at each process step 5) Assembly Instructions The documents should be reviewed to ensure that these documents are complete and have the required integrity to make the PFMEA meaningful. 60

61 STEP 2: Complete the Process Step and Requirement columns of the PFMEA using the information collected in STEP 1. For each Operation / Process Step list out the design features / characteristics to be created at that step (taken from the Characteristic Matrix, Part Drawing and related Specification(s)). The description of the design requirements must be in sufficient detail so that the Failure Modes can be easily identified. Include the specifications or acceptance criteria for each feature listed. Figure 26: Completing the Process Step and Requirements Column Ideally this step should be completed in xfmea (or similar FMEA software) so that it can easily link to the Reference PFMEAs. Although PFMEAs should be completed for every feature included within the Design Definition there are some allowable exceptions and care points that should be considered. A) Patterns of Features The Risk Profile (RPN) of a feature within a PFMEA is derived from three attributes; Potential impact of the non-conformance (Severity Score), related to the purpose of the feature, Probability of it happening (Occurrence Score), related to the process capability and hence specification(s) limits, and Ability to detect it, if it was nonconforming (Detection Score). 61

62 Thus if there are multiple features that have the same purpose, same specification, made in the same way (and at the same step), and inspected in the same way then these features may be considered as a pattern and a single line item within the PFMEA. An example of this may be the bolt holes used to secure one part to another. Let s say there were 26 holes used then these could be considered as one feature in the PFMEA. Figure 27: Hole Pattern Example B) Profile Features Some parts may have a specified profile with multiple inspection points identified to define how this should be inspected. Do not confuse inspection points with features. The feature in the PFMEA is Profile Shape and not the 100 inspection points that may be identified on the drawing. For example on a Fan Blade there are several profile areas defined along the Blade with different Design Consequences if they were non-conforming. The Profile areas are specified on the drawing to take account of this. Each profile area that is separately defined should be included on the PFMEA as a separate feature. 62

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