Validation Testing Participants Alpine Electronics (Europe) GmbH ‘Accuride Corporation Adient ‘axalta Coating Systems BENTELER Automobiltechnik GmbH Delphi Dr. Schneider Holding GmbH EBK Kriiger GmbH & Co. KG Faurecia Automotive GmbH F&P America Manufacturing Gunite Heinrich Huhn GmbH + Co.KG IMS Gear SE & Co. KGaA Iroquois Industrice Litens Magna GETRAG B.V. & Co. KS Magna International inc. Mayco International LLC Paul Craemer GmbH PWO Progress-Werk Oberkirch AG Wabco GmbH Wallstabe & SchneiderTABLE OF CONTENTS FOREWORD ACKNOWLEDGEMENTS. TABLE OF CONTENTS... INTRODUCTION. 1 2OBIECTIVES AND Laas OF FMEA 1B InTEGRATON oF FMEA DV THE COMPANY. 4.3.1 Potential Considerations of the FMEA 4.3.2 Senior Management Commitment. 113.3 Know-How Protection ofthe Design FMEA/Process FMEA 1.3.4 Agreements between Customers and Suppliers. 41.3.5 Transition trotepy.. ia 4.216 Foundation and Fanily MCAS, {LAA FMEA ror Prooucrs ano Paaceses 1.4.1 Design FMEA... 41.4.2 Process FMEA. 41.4.3 Collaboration between FMEAS. 11S Paniecr Pann 41.5.1 FMEA inTent.. 1.5.2 FMEA Timing. 1.5.3 FMEA Team, 1.5.4 FMEA Tasks 1.5.5 FMEA Tools 1.6 FMEA METHODOLOGY. ‘2 EXECUTION OF THE DESIGN FMEA. 2.1 DESIGN FMEA 1st STEP: PLANING AND PREPARATION 2.1.1 Purpose 2.12 DFMEA Project identification end Boundaries 2.13 DFMEA Project lan an 2.14 Idenication ofthe Baseline DFMEA 2.1.3 DEMEA Header. i 2.1.6 Basis for Structure ANAIYSS on 2.2 Design FMEA 2no STE: STRUCTURE ANALYSS. 22.1 PUPOSE nnn 2.2.2System Structure. 2.2.3 Define the Customer: 2.2.4 Visualize system Structure 22.5 Collaboration between Customer and Supplier 2.2.6 Basis for Function Analysis, 2.3 DESIGN FMEA 380 STEP: FUNCTION ANAL 23.1 Purpose 2.3.2 Function 2.3.3 Requirements 2.3.4 Parameter Diagram (P Diagram 2.3.5 Function Analysis2.3.6 Collaboration between Engineering Teams (Systems, Safety, and Components) 2.3.7 Bass for Foilure Analysis. : 2.4 DESGN FMEA 4 STEP: FAURE ANALYSIS 2.4.1 Purpose. 24.2 Failures. 2.43 The Failure chain. 2.4.4 Foilure Effects. 2A. Failure Made. 2.4.6 Failure Cause. 2.4.7 Failure Analysis... 2.4.8 Failure Analysis Documentation 2.4.9 Collaboration between Customer ond Super ‘atlure Efecs). 2.4.10 Basis for Risk Analysis. a 2.5 DESIGN FMEA Sti STEP: isc ANALSS. 25.1 Purpose 2.5.2 Design Controls. 25.3 Current Prevention Controls (PC). 2.5.4 Current Detection Controls (DC) 12.5 Conpirmation of Current rrevention and Wetection Contras. 2.56 Evaluations. 25.7 Severity (S) 25.8 Occurrence (0) 2.5.9 Detection (0). 2.5.10 Action Priority (AP). 25:11 Collaboration between Customer and Supplier (Severity). 2.5.12 Basis for Optimization venoms 2.6 DESIGN FMEA 61H Srer: OPIMIZAION 26.1 Purpose 0 26.2 Assignment of Responsibiltis... 2.6.3 Status ofthe Actions 2.6.4 Assessment of Action Effectiveness. 2.6.5 Continual Improvement 2.66 Collaboration between the FMEA team, Management, Customers, ft Suppers egardg Potente Failures. a I6 2.7 Desion FMEA 7” Sr: RESULTS DOCUMENTATION. 76 2.7.1 Purpose 76 J ERLUUIION OF THE PROCESS FMIEA (PFIMEA) : 79 3.1 Process FMEA 1ST STEP: PLANNING ANO PREPARATION. 2.1.1 Durpore. 3.1.2 PEMEA Project identification and Boundaries. 3.1.3 PFIMEA Project Plan 4.1.4 laentineaton of the vaseline PFMEA. 3.1.5 Process FMEA Header. _ 3.2 Process FMEA 2uo Step: STRUCTURE ANALS, 3.2.1 Purpose. 13.2.2 Process Flow Diagram.. 32.3 Structure Tree 2.24 Collaboration between ister Sip eginerig teams (reoc responsies) 87 3.2.5 Bass for Function Analysis... $5.5 PROCESS HVE S80 STEP: FUNCTION AALS. 3.3.1 Purpose...33.2 Function. 13.3.3 Requirements) (Characteristics)... 3.3.4 Visualization of functional relationships a 3.35 Collaboration between Engineering Teams (Systems, Sejety, and Components). 2.26 Racie for Frilure Anaysie ne 3. Process FMEA 41h SreP: FAURE ANAL. 3.4.1 Purpose 3.4.3 The Falure Chalten 3.4.4 Failure Effects si 3.4.5 Failure Mode. — 3.4.6 Failure Cause: 3.7 Failure Analysis. 13.4.8 Relationship between PEMEA and FMEA... 3.4.9 Failure Analysis Documentation. 3420 Colabortin between Customer and Supper tat 3.4.11 Basis for Rsk Analysis [35 PROCESS FMEA Sra STEP: Rist ANALY 3.5.1 Purpose 315.2 Curent Prevention Controls (PC) 3.5.3 Current Detection Controle (NC) 3.5.4 Current Prevention and Detection Control... 43.5.5 Eveluations. 2.0 seventy). 35.7 Occurrence (0) « 35.8 Detection (0). 3.5.9 Action Priority (AP). 4.5: collaboration betwen Customer nd Supper (Severity) 3.5.11 Bass for Optimization... 34 PROCESS FMEA 61H STEP: OPTIMIZATION 3.6.1 Purpose. 3.6.2 Assignment of Resporsibiies.. 3.6.3 Status of the Actions 3.6.4 Assessment of Action Effectiveness 3.6.5 Continucl Improvement. 3.6.6 Collaboration between the FMEA team, Management, Cstomers, and Suppliers regarding Potential Failure 3.7 Pocess FMEA 7" Ste: RESULTS DOCUMENTATION. 3.7.1 Purpose. 3.7.2 FMEA Report. ‘4 SUPPLEMENTAL FMEA FOR MONITORING AND SYSTEM RESPONSE (FMEA-MSR) 4.1 FMEA-MIR 1st STE: PLANNING AND PREPARATION. saga 125 4.1.1 Purpose... 126 {4.1.2 FMPA-nMsR broject Identification and Boundaries. “27 4.1.3 FMEA-MSR Project Plan. ” 4.2 FMEA-MSR2N0 STEP: STRUCTURE ANALYSE 4.2.1 Purpose. 42.25tructure Trees. 4.3 FIMEA-MSR 380 STEP: FUNCTION ANALSS, 43.1 Purpose. AA PMEA-MSR ain Sten: Fane ANAL4.4.1 Purpose... 4.4.2 Failure Scenario, 4.4.3 Failure Cause. 4.4.4 Failure Mode. 4.4.5 Failure Effet on 4.5 FMEA-MSR STH Sp: Rsk ANALYSIS 4.5.1 Purpose. 415.2 Evaluations. 4.5.3 Severty (5) 4.54 Rationale for Frequency Rating. 4.3.9 rrequency (¢) 45.6 Current Monitoring Controls. 45.7 Monitoring (M) on 45.8 Action Priority (AP) for FMEAMSR. 44.6 FMEA-MISR i Srep: OPrmazariON... “46:1 Purpose 4.6.2 Assignment of Responsibilities ou. 4.6.3 Status of the ACtIONS oo = 44.5.4 Assessment of Acton EECLVENESS 4.65 Continuous Improvemert... 4.7 FMEA-MSR 7” Sep: RESULTS DOCUMENTATION 4.7.1 Purpose 4.7.2 FMEA Report. APPENDIX... . ‘A Saopue FMEA Fon Siers 1B FoRMSHEETS—SreP ay SreP HINTS... ~ (© Seveniy, OccuRseNct, DETECTION AND ACTION PRIORITY TABLES 18s D Avoinons: 210 E _Funrien Arrucamion Fiewos 213 F CHANGE POINT SUMMARIES nnn ate Seen Ts REFERENCES AnD SUGGESTED READINGS... 235 H Glossar. a 236 Table of Figures, FicuRe1.4-1 FMEA COWABORATION. FicuRe1.5-1 FMEA TIMING AUGNED Wi APOP PHASES. FIcuRE1 5-2 FMEA TIMING AUGNeD TO MILA Phases Figure 1.6-1 FMEA7Sre® APpROKch. FicuRe2.1-1 EYAMPLEOF COMPLETED DFMEA HEADEx PUAN AND PREPRRATONSTC FicuRe2.2-1 Bxannt# oF BLock/BOUNDARY Dias. FIGURE 2.2-2 _EXAMPLEOF STRUCTURE ANALYSIS STRUCTURE TREE... FiGURE 2-2-3 EXAMPLEOF STRUCTURE ANALYSES FORM SET Ficune 23-1 Input/Inrerrace/OUTPUT FLOW. FIGURE 23-2 EXAMMLEOFSYSTEMBEKAVIOR.. . FIGURE2.3-3 EXAMPLEOF PARAMETER DAGRAM WITH ELECTRICAL MOTOR Ficure 2.3-4 EXAMPLcO# FUNCTION ANALYS'S STRUCTURE TREC. FIGURE 2.3-5 _EXAMPLEOF FUNCTION ANALYSIS FORM SHEET. Figure 24-1 TPES OF FAURE MODES.. etd ¢-12- Ficure2.4-2 Ficure2.4-3, Fcure 2.4-8 Fecure2.4-5 Fic 74-6 Ficune 24-7 Floune 24-8 Proune 26-9 Fecure 25-1 Ficure 25-2 Ficure2.5-3 Ficure 26-4 Figure 31-1 Fioure 31-2 Faure 32-1 Figure 32-2 Ficune 32-3 Fiouae 32-4 Frouae 32-5 Ficure 33-1 Frans 22.9 Ficune 33-3 Fioune 34-1 Foun 34-2 Flours 34-3, Figure 34-4 Ficuee 3.45 FisuRe 3.46 FicuRe 34-7 Ficune 35-1 Ficune 35-2 Froure 35-3 Figure 36-1 Frcure 41-1 Froure 42-1 Func 2-2 Fioure 2-3 Froune 49-4 Fecure 43-2 FecuRe 44-1 FecuRe 4.4.2 Frcune 4.03 Prcune 4.08 Ficune 4.45 Freunca.a 6 Ficure 4.47 Ficure 44-8 Froune 4 5-1 Derinmon oF A FAURE. “THEORETICAL FARE CHAN MODE, Fa. STRUCTURE AT OFFERENT LEVELS, [EXAMPLE OF FAKLURE ANALYSIS STRUCTURE TREE. EXAMPLE OF FALE ANALYSIS FORM SHEET ‘View oF ProDUcT ENO ITEM-FUNCTION-FALURE FORM SHEET... ‘Yew oF Focus Tew ELEMENT-FUNCTION-FALURE FORM SHEET. ‘Yew oF Lowen Leve reef UNETION-FAMURE FORM SECT Prevention ANO DETECTION IN THE DESIGN FMEA... ROADMAP OF DESIGN UNDERSTANDING EXAMPLE OF DFNIEA Risk ANALYSIS FORM SHEET. ExanPLe oF DFMEA Orrization Win NEW Rk EVALUATION FRM SEY. [DEMONSTRATION OF THE PROCESS FOR NARROWING THE PREPARATION [EXAMPLE OF COMPLETED PFMEA HEADER PREPARATION (STEP 1)... Process Flow Diaceam. pa ‘hanmc F Srnucrute Anawyos Sravcrone TAFE (ELTNCAL MOTOR ASSEMBLY LN) ve acess ITM. PaacessSTERS.. EXAMPLE OF STRUCTURE ANALSIS Font SHET.. EXAMPLE OF PARAMETER DIAGRAM OF PRESS IN SINTERED BEARING Faante rf FUNCTION ANALYSs STRUCTURE TREE. ExAMELE OF FUNCTION ANALYSIS FORM SHEET. ‘THEORETICAL FALURE CHAN MODEL. Examen oF Faun Arai STRUCTURE TRE EXAMPLE OF FALURE ANALYSIS FORM SHEET. RELATIONSHIP BETWEEN PFMEA an OFMEA. View oF PROceSsITew-FUNCTION-FALLIRE FORM SHEE. \iew oF Process Srep-FuNCTiON-Faute For SHET ‘View oF PRacess Wonk Ec T-FUNCTION- FLUE FORM SHEET. PREVENTION AND DETECTION IN THE PROCESS FMEA... ROADMAP OF PROCESS UNDERSTANDING. EXAMPLE OF PFMEA wrt Risk ANAL¥Is FOR SHEET 103 105 1105 118 EXAMPLE OF PFMEA OPTIMIZATION WITH NEW Risk EVALUATION FORMA SHEE AQ Gene BLOCKOINGRAN OFAN ELEC. / ELECTRON / PROGRAM ABLE ELECRONI SYSTEM 1B [EXAMPLE OF ASTRUCTURE TREE OFA WIMDOW LIFT SYSTEM FOR INVESTIGATING ERRONEOUS SGNALS, MONITORING, AND SISTEM RESPONSE sen 129 vate ne TRUITT AFF OF & SMART SSO WITH AN INTERNAL SENSING ELEMENT AND OUTPUT TO AN wreneace feat OF STRUCTURE ANALY The FMEACMISR FoR SET {Caanirie ara Smuerune Tet wi FUNCTIONS. Exar OF FUNCTION ANANSI FMEA-MISR FoR SET “THEORETICAL FALURE HAN MODEL DFMEA Ano FMEA-MR... Fane Scenamo (1) - Non-HAZARDOUS. Faire Scenamo (2) -HazanooUs.. Faure Scena (3) -Mecareo (EFC). net [ExaMPE OF A STRUCTURE WIT FALURE CHAIN WITHOUT A MONITORING OR WITH AMONTIORING WHICHIS ONLY PARTIALLY EFFECTIVE (scenARO (1) AND (2) 135 {WITCHES THE SYSTEM TO A MITGATED FALURE EFECT (SCENARIO (3). 2136 [EXAMPLE OF AFALURE NETWORK... = 136 [EUAMPLEOF PALURE ANAL INFMIEA-MISR FoR SHEET. a0 FMEA-MSR MonITORIG NOT #PLEMENTED OR NOT CONSIDERED dAFicUne4.5:2 _ FMEA-MSR RELIABLE DAGhOsTIC MONTORING « 1. FIGURE4.S-3_FMIEA-MSR DIAGNOSTIC MONTORING PARTIALLY EFFECT... - nA FcuRe4.5-4 Exawnic or FMEA-MSR Risk ANALSS EVALUATION OF Cunmenr Risk Fone SHEET... 149 FIcURE4.G-1 — EXAMnLEOF FMEA-MSR OPTIMIZATION WT NEW RIKEVALUATION FORM SHET 152 Table of Tables TABLE DL- DEMEA SEVERIIY (3) TasueD2 -DFMEA Occurrence (0). ‘Taste D3 -DFMEA DETECTION (0)... ‘TABLE AP ACTION PRIORITY FOR DFMEA avo PFMEA ‘Taste PL -PFMEA SEVERITY (5). ‘Tanue P2-PFMEA OCCURRENCE (0). ‘TABLE P3 -PFMEA DETECTION (0) 7 TaSLE AP~ ACTION PRIORITY FOR DFMEA ano PFMEA ‘TABLE MSR ~ SUPPLEMENTAL FMEA’ MIR SEVERITY (8) “TABLE MSR2 ~ SUPPLEMENTAL FMEA-MSR FREQUENCY (Fs ‘Taste MSR3 -SurPLEWENTAL FMEA-MSR MONITORING (M) ‘TABLE AP ACTION PRIORITY FOR FMEA-MIR.. ‘i a13-14 1 INTRODUCTION This joint publication is the culmination of more than three years of collaboration between OEM and Tier 1 supplier members of the Automotive Industry Action Group (AIAG), and the Verband dor ‘Automobilindustrie (VDA). The text has been completely rewritten, and the FMEA method has been revised in a few key areas. The intent is to provide a common foundation for FMEA across the ‘sectors of the automotive industry which are represented by these feganizatinns. While every affort was mada to achiava cansensiis, it may be necessary to refer to individual corporate publications or Customer-Specific Requirements (CSR). ‘Anew method, Supplemental FMEA for Monitoring and System Response (FMEA-MSR), has been added. It provides a means for the analysis of diagnostic detection and faull mitigation during ‘customer operation for the purpose of maintaining a safe state or state of regulatory compliance. ‘This handbook supersedes AIAG 4th Edition FMEA and VDA, “Product and Process FMEA" Volume 4 Purpose and Description ‘The industry is challenged by increasing quality demands of the customer, the necessary cost optimization of the products and processes, and higher complexity, as well as the product liability of the designer and manufacturer required by legislation. Therefore, the FMEA method is used to address the technical aspects of risk reduction. Failure Mode and Effects Analysis (FMEA) is a team-oriented, systematic, quaitative, analytical method intended to: ‘evaluate the potential technical risks of failure of a product or process ‘+ analyze the causes and effects of those failures ‘+ document preventive and detection actions, ‘+ recommend actions to reduce risk Manufacturers consider different types of risk including technical risks, financial risks, time risks, and strategy risks. The FMEA is used tor analyzing the technical risks to reduce failures and improve safety in the products and processes. Figure 1.1-1 shows the scope of FMEA and this handbook, = 18-Tea Re ER] [Fears Fieram —_——] [orang mae | (eee, |[Eeeemm | [erate tremens | Somaiemetee | Cheeemrsram” | |Saetsacgthe = a ar | Seater score ||” evrorscore || ovrorscore || _—_ourorscone Figure 1.11 Aspects of Risks 4.2 Objectives and Limits of FMFA The objective of FMEA is to identiy the functions of a product or steps of a process and the associated potential failure modes, effects, and causes. Furthermore, itis used to evaluate whether prevention and detection controls already planned are enough, and to recommend adtitional actions. The FMEA documents and @) tracks actions that are taken to reduce risk. The FMEA ‘methodology helps engineers prioritize and focus on preventing product andor process problems from occurring Business objectives exist that are supported by the FMEA and other activities, such as: + Increasing the quality, reliability, manufacturat serviceability, and safety of automotive products '* Ensuring the hierarchy, linkage, interface, and cascading and alignment of requirements between components, systems and vehicles are captured = Reducing warranty and gnaduill casts ‘* Increasing customer satisfaction in a highly competitive market '* Proving product and process risk analysis in the case of product liability + Reducing late changes in development Maintaining defect-free product launches ‘+ Targeting communication in internal and external customer and supplier relationships Building up a knowledge base In the company, I., Jocuri lessons-leamed q -16-4.3 Integration of FMEA ‘+ Complying with regulations in the registration approval of the components, systems, and vehicles Limitations of the FMEA include the following: «tts qualitative (euibjectiva), not quantitative (measurable) ‘+ Itis a single-point failure analysis, not a multi-point failure analysis ‘+ _Itrelies on the team’s level of knowledge which may, or may not predict future performance ‘+ Itis a summary of the team's discussions and decisions, therefore, the quality of the FMEA report is subject to the recording skill of the team which may reflect the discussion points in whole, or in part (tis not a transcript of a meeting) For quantitative analysis and multi-point failure analysis, other methods such as FTA (Fault Tree Analysis) and FMEDA (Failure Modes, Effects, and Diagnostic Analysis) are used. These are the methods which can calculate and analyze the relevant metrics (eg., single-point failure analysis, multi-point faults, latent faults) to reach a quantified analysis rasiilt the Company FMEA is a multi-disciplined activity affecting the entire product, realization process. The implementation of FMEA needs to be well planned to be fully effective. The FMEA method is an integral element of Product Development and Process Development activities. The FMEA can reduce product redevelopment timing ‘and cost. It supports the development of comprehensive specifications, test plans, and Control Plans. 1.3.1 Potential Considerations of the FMEA The competent performance of the FMEA and the implementation ofits results are among the responsibilities of companies that design, manufacture, and/or assemble products for the automotive industry. Itis critical that the analysis take into consideration the product's operating conditions during its useful lfe, particularly with regard to satety risks and foreseeable (but unintentional) misuse. When the FMEA Is performed, tne following norms are observed: * Clear: potential failure modes are described in technically precise, specific terms, enabling a specialist to assess failure ‘causes and possible effects. Descriptions are free from possible misunderstanding. Emotion-laden terms, (@.9, dangerous, intolerable, irresponsible, ete.) are not appropriate.=18- ‘+ True: the consequences of potential failures are described accurately (e.g., potential for odor, smoke, fire, etc). + Realistic: failure causes are reasonable. Extreme events are not considered (e.9., falling rock on road, no power to ‘manufacturing plant, etc.). Failures resulting from misuse relative to perception, judgement, or action are considered foreseeahie when documented by systematic methods (including brainstorming, expert judgement, field reports, use case analysis, etc.). Failures resulting from intentional misuse (@.g. deliberate manipulation and sabulags) are not considered. ‘+ Complete: foreseeable potential failures are not concealed. Concern about revealing too much know-how by creating a correct and competent FMEA is not a valid reason for an incomplete FMEA. Completeness refers to the entirely of the product/process under analysis (e.g., system elements and functions). However. the depth of detail depends on the risks involved Technical risks of failure identified in the FMEA are either assessed as acceptable, or actions are assigned to further reduce risk. The closure status of actions to reduce the risk is ducurtierile 4.3.2. Senior Management Commitment ‘The FMEA process can take considerable time to complete. A ‘commitment of the required resources is vital. Active participation of the product and process owners and commitment from senior management are important to successful FMEA development. Senior management carries the responsibilly for the application of FMEA. Ultimately, senior management is responsible for acceptance of the risks and risk minimization actions identified in the FMEA. 1.3.3 Know-How Protection of the Design FMEA/Provess FMEA ‘The sharing of intellectuzl properly four in the Design FMEA and/or Process FMEA between suppliers and customers is governed by contractual aareements between suppliers and customers and is beyond the scope of this handbook. 1.3.4 Agreements between Customers and Suppliers The Customer Specific Requirements regarding FMEA should be coordinated with the parties involved andlor the suppliers. An agreement made about the execution of FMEAs may include but is not limited to items such as system boundaries, necessary work documents, analysis methods, and evaluation tables.1.3.5. Transition Strategy Existing FMEAs developed using the previous AIAG 4th Edition FMEA "Product and Process FMEA" of VDA Edition, may remain in their original form for subsequent revisions. ‘The organization should thoughtfully plan the transition from their ‘current FMEA process(es) and methods to the new AIAG & VDA FMEA process and tools. When practical, existing FMEAs used as. a starting point for new programs should be converted to reflect the new rating scales, analytical methods. and format. However. if the team determines that the new program is considered a minor change to the existing product, they may decide to leave the FMEA in the existing format. ~ New projects should follow the FMEA method presented in this Handbook unless company leadership and Customer Specific Requirements (CSRs) mandate a different approach. The transition date and project milestone after which new projects, follow this method should be defined by the company taking into consideration Customer Specific Requirements. 1.3.6 Foundation and Family FMEAs Foundation and family FMEAs are recommended to he created and used as a basis for new analyses. These optional practices provide the greatest opportunity to leverage past experiance and knowledge and ensure that knowledge is accumulated over product lfecycies and that prior performance issues are not Tepeated (lessons leamed). Furthermore, such reuse also reduces effort and expenditures. Foundation FMEAs (also known as generic, baseline, template, core, master, or best practice FMEAS, etc.) are FMEAs that contain knowledge of the organization ftom prior developments which make them useful as a starting point for new FMEAS. The foundation FMEA is not program specific, therefore the generalization of requirements, functions, and measures is allowed. Family FMEAs are specialized foundation FMEAs. Itis common to ‘develop products that generally contain common or consistent product boundaries and related functions (a Product Family) or processes which contain a series of operations that produce ‘multiple products or part numbers. In these cases, itis appropriate to develop Family FMEAs which cover the commonalities for these Families. When using the family or foundation FMEA approach for the new product or process under development, the team should identify and focus the analysis on the differences between the existing and the new product, process or application. The information and ratings carried over from the family or foundation are to be -19--20- critically examined with regard to the respective use case and ‘experiences from the known application. FMEA for Products and Processes ‘There are three basic cases for which the FMEA is to be applied, each with a different scope or focus. Case 1: New designs, new technology, or new process. The scope of the FMEA ie tho complote design, technology, or process, Case 2: New application of existing design or proces: ‘The scope of the FMEA is an existing design or process in a new environment, location, application, or usage profile (including duty cycle, regulatory requirements, etc.). The scope of the FMEA should focus on the impact of the new environment, location, or application usage on the existiny Uesiy!! ur piucess, Case 3: Engineering changes to an existing design or process, New technical developments, new requirements, product recalls, and roports of failures in the field may drive the need for design andlor process changes. In these cases, a review or revision of the FMEA may be necessary. ‘The FMEA contains a collection of knowledge about a design or process and may be revised after start of production if at least one Of the following points applies: ‘+ Changes to designs or processes ‘+ Changes to the operating conditions + Changed requirements (e.g, aw, norms, customer, state of the art) + Quality Issues, ( e.9., Plant experience, zero mileage, or field fovea, intemal | external complaints). + Changes to the Hazard Analysis and Risk Assessment (HARA) ‘* Changes to the Threat Analysis and Risk Assessment (TARA) + Findings due to product monitoring + Lessons leamed There are two main approaches to FMEA: the analysis according to product functions (Design FMEA) or according to process steps (Process FMEA),1.41 Design FMEA ‘A Design FMEA (OFMEA) is an analytical technique utilized primarily by a design responsible engineer/team as a means to assure that, to the extent possible, potential Failure Modes and their associated Causes or mechanisms of failure have been considered and addressed prior to releasing the part to produetion. The Design FMEA analyzes the functions of a system, subsystem, ‘or component of interest as defined by the boundary shown on the Block/Boundary Diagram, the relationship between its underlying elements, and to external elements outside the system boundary. This enables the identification of possible design weakriesses to minimize potential risks of failure. A System DFMEA Is comprised of various subsystems and components which are represented as system elements (items), System and subsystem analyses are dependent on the viewpoint or responsibilty. Systems provide functions at the vehicle level. These functions cascade through subsystems and components. For purpose of analysis, a sub-system is considered the same way as a system Interfaces and interactions among systems, subsystems, the environment and the customers (¢.g, Tier N, OEM, and end user) may be analyzed in System FMEAs, Within a system there may be software, electronic, and mechanical elements. Examples of systems include: Vehicle, Transmission System, Steering System, Brake System or Electronic Stability Control System, etc. ‘A component DFMEA is a subset of a system or subsystem DFMEA. For example, an Electrical Motor is a component of the Window Lifter, which is a subsystem of Window Lifter System. A Housing for the Electrical Motor may also be a component or part. For this reason, the terms “system element” or “item” are used regardless of the level of analysis, Design FMEA may also be used to assess the risks of failure of products such as machines, and tooling. ne from the analysis may be used to recommend design changes, additinnal testing, and other actions which reduce the risk of failure or increase the ability of a test to detect failures prior to delivery of the design for production. 1.4.2 Process FMEA In contrast to the Design FMEA (DFMEA), which analyzes the sre possibilities that may be created during the design phase of ‘the product, the Process FMEA (PFMEA) analyzes the potential failures of manufacturing, assembly and logistical processes to 21+[produce products which conform to design intent. Process-related failures are different than the failures analyzed in the Design FMEA, ‘The Process FMEA analyzes processes by considering the potential feilure modes which may resul frum proves variation, (0 establish priority of actions for prevention, and as needed, improve controls. The overall purpose is to analyze processes and take action prior to production start, to avoid unwanted defects related to manufacturing and assembly and the consequences of, those defects, 1.4.3 Collaboration between FMEAS: There are opportunities for collaboration between both Design and Process FMEAs in the same company and outside of the company. To help communicate effects and severities, a joined and agreed to severity evaluation can be reviewed between organizations (different enmpanias in the supply chain starting with Tier 1, Tier 2, Tier 3, etc.) as shown in Figure 1. Goal: Risk to End User reduced Failure Effects and Severity (as possible / as needed) “Seventy Ga Technical risk analysis and proposed product or process changes (as possible / as needed) Goal: Collaboration between Customer and Supplier, Figure 1.41 FMEA Collaboration