D 3 EXECUTION OF THE PROCESS FMEA (PFMEA) 3.1 Process FMEA ‘st Step: Planning and Preparation 3.4.4 Purpose ‘The purpose of the Process Planning and Preparation Step isto f describe what product/processes are fobs included or excluded for review in the PFMEA project. The process takes into account that all processes within the {acilty can be analyzed or reanalyzed using PFMEA. This process allows an organization to review all processes at a high level and to make a final determination for which processes will be analyzed. The overall advantage of Preparation isto focus resources on processes withthe highest priority. ‘Tho main objectives of the Process Planning and Preparation Step are ‘+ Projectidentfcation ‘+ Project plan inTent, Timing, Team, Tasks, Tools (ST) ‘+ Analysis boundaries: Whats included and excluded from the analysis ‘+ Identification of baseline FMEA with lessons leamed ® + Basis for the Structure Analysis step. 3.4.2 PFMEA Project Identification and Boundaries PFMEA Project identification includes a clear understanding of what needs to be evaluated. This involves a decision-making ‘process to define the PFMEAs that are needed for @ customer rogram. What to exclude can be Just as important as what to Include In the analysis, alow are some basic questions that help identify PFMEA projects ‘© What is the customer buying from us? ‘= Ate there now requirements? ‘+ What specific processielements cause a risk in imparting the requirementcharacteisic? ‘Does the customer or company require a PEMEA? + Dowe make the product and have design contro? + Dowe buy the product and sill have design contro!? + Dowe buy the product and do not have design contro? + Who is responsible forthe interface design? + Dowe need a system, subsystem, component, or other level > of analysis? -79-‘Answers to these questions and others defined by the company help create the ist of DFMEA projects neeced. The PEMEA project list assures consistent direction, commitment and focus. ‘The fallowing may assist the team in defining PFMEA boundries, as available + Legal requirements + Technical roqurements ‘+ Customer wanis/needs/axpectation (extemal and internal customers) ‘+ Requirements specication ‘+ Diagrams (Block/Boundary/System) ‘+ Schematics, drawings, and/or 3D models + Billof Materials (BOM), Risk Assessment + Previous FMEA for sinilar products + Error proofing requirements, Design fo- Manufacturabilty and ‘Assembly (DFMIA) ‘+ QFD Quality Function Deployment Preparation needs to be established atthe start ofthe process to assure consistent direction and focus, @.9..an entire process line, process item / process element Processes within the plat that can impact the product quality and can be considered for PFMEA analysis include: receiving processes, part and material storage, product and material delivery, manufacturing, assembly, packaging, labeling, completed product iransportation, storage, maintenance processes, detection processes and rework and repair processes, etc.Figure 3.1-1 Demonstration of the process for narrowing the Preparation The following may be consider defining the scope of the beer Sempre ey foe een *attety try tae ome ® Se ee ee + Complexity of Design + Safely of people and systems + Cyber-Physical System (Including cybersecurity) + Legal Compliance + Catalog and standard parts items that may assist in determining whether an existing PFMEA ‘should be included in the final scope: ‘+ New development of products end processes. ‘+ Changes to products or processes ‘+ Changes o the operating condtions ‘+ Changed requirements (laws/regulations, standards/norns, customers, state ofthe art) ‘+ Manufacturing experience, 0 km issues, o eld issues / Warranty + Process failures that may cesultin hazards + Findings du to internal product monitoring + Ergonomic issues + Continuous Improvement3.4.3 PFMEA Project Plan ‘A plan forthe execution ofthe PFMEA sheuld be developed once the DFMEA project is known, Itis recommended thatthe ST method (Intent, Timing, Team, ‘Tasks, Tool) be used as descrived in secon 1.5 ofthis handbook. “The organization also needs to factor in developmant of the applicable Customer Speciic Requirements) (CSRs) methods ‘andlor deliverables int the project plan, The plan fr the PFMEA helps the company be proactive in stating the PFMEA early. The DFMEA activities (7-Stop process) should 2¢ incorporated into the ‘overall project plan, 3.4.4 Identification of the Baseline PFMEA, Part of the preparation for conducting the PFMEA is knowing what information is already available that can help the cross-functional team, This includes use ofa foundation PFMEA (described in Section 1.3), similar product PFMEA, or product foundation FMEA. The foundation PFMEA Is @ specialized foundation process FMEA for products that generally contain common or Consistent product boundaries and related functions. For a new product inthe foundation, added to this foundation PEMEA would be the new project specific components and functions to complete the new product's PFMEA. The addltions for the new product may bbs in Une fourcaton PFMEA itself or In a new document it referance tothe original family or foundation PMEA. Ino baseline is available, then the team will develop @ new PFMEA. 3.4.8. Process FMEA Header During Preparation, the header ofthe PEMEA document should be filed out. The header may be modified o meet the needs of the organization and inctudes some ofthe basic PFMEA Preparation information as follows:‘Company Name: Name of Company Responsibie of P>MEA ‘Manufacturing Location: Geographical Location ‘Customer Name: Name of Customer(s) or Product Family ‘Model Year / Pregram(s): Customer Application or Company ‘Model /Stylo ‘Subject: Name of PFMEA proje [PFMEA Start Date: Start Date FMEA Revision Date: Latest Revision Date ‘Cross-Functionsl Team: Team: Team Roster needed FMEA ID Numter: Determined by Company Process Responsibility: Name of PFMEA owner ‘Confidentiality Level: Business Use, Proprietary, Confidential ‘Planning and Preparation (step 1) Company Name: Moves fog Fi. seorom Manstactring ete Ccontemar Name: boty Modal Yama) OP Peoria ona ‘ealer2018 esa bo oe pecan S02 ent on — Gor Poa Mea Stine Figure 3.1-2 Example of Completed PFMEA Header Preparation (Step 1) 3.2 Process FMEA 2nd Step: Structure Analysis 3.24 Purpose @ q “The purpose of Process Structure Analysis is to dently and breakdown the manufacturing system into Process items, Process sleps, and Process Work Elements. ‘The main objectives of a Process Structure Analysis ar: ‘+ Visuatzation of the analysis scope ‘+ Structure tree or equivalent: process flow diagram ‘+ Identifcation of process steps and sub-steps. + Collatoraton between customer and supplier engineering teams (Interface responsibilities) ** Basis or the Function Analysis step -83-{A Process Flow Diagram or a Stucture Tree helps define the process and provide the basis for Structure Analysis. Formals ¢ ‘may vary by company inciuding the use of symbols, symbol type ‘and thelr meaning. A Process FMEA is intended to represent the process flow as it physically exists when ‘walking the process,” Process Work Element) Pal Why implement the product / process requirements - from leftto right (Process Werk Element -> Process Step -» Process iter) 3.3.3 Requirement{s) (Characteristics) ‘A.Characteristc isa distinguishing feature (or quantifiable atibute) of a product. For example, a diameter or surface finishes. For PFMEA, Requirements are described in terms of Product Characteristics and Process Characteristics. Note: The negative of these wil be the Failure Mode and the Failure Cause. ‘A Product Characteristic (Requirement) is related to the performance of a process function and can be judged or ‘reagured. A product characteristic is shown on a product drawing for speciicaion document e.9., Geometry, Mate‘al, Surface Finish, Coatings, etc. Process functions create product characteristics, The design documents comprefend legal requirements (e.g, lead-free material), industry requirements (e9 ‘tyead class), customer requirements (2.g., quantiy), and intemal requirements (e.g. part cleanliness), Product characteristics can ‘be measured after the product has been made (e.g. gap). Product -29-Characteristics can come from performance requirements, 2.9, iegal (performance of windshield wipers). In these cases, the measurable Product Characteristic should be listed, followed by the Performance Requirement, eg., Spine Over-pin Diameter (Government Windshield Wiper Regulation XYZ). The specific {quantitative vale is optional for the PFMEA form shot Product Characteristics: + May be derived from various sources, external and internal Legal requirements: + Compliance with designated health & safely and ‘environmental protection regulations. Industry Norms and Standard + 180.9001, VDA Volume 6 Part 3, Process Audit, SAE J1739 Customer Requirements: + Accarding to customer specifications, e.9. adherence to required quality, manufacture and provision of products) in time x and quantity y (output zhour) Internal Requirements: + Manufacture of tha product, n process cycle, compliance with ‘expected production costs (e.9,.facities availabilty, limited rejects, no corective work), production system principies, process quality and cleanliness instructions Process Characteristics: + AProcess Characteristic Is the process conto that ensures: the Product Characteristic is achleved by the process. It may be shown on manufacturing drawings or specications (Including operator work instructions, set-up instructions, terror-proofing vacation procedures, etc), Process: characteristics can be measured while the product is boing ‘made (e.g. press force), The specific quantitative value is optional forthe PFMEA form sheet.7 arta ao eee imap |Samtceetpce | Sener oe ferrocene Secrest feces Sener on eh tet Figure 3.31 Example of Parameter Diagram of Press in Sintered Bearing 3.34 Visui ization of functional relationships “The inleraction of process item functions, process step functions ‘and process work element functions may be visualized as function ‘network, function structure, function ree, and/or function analysis. ‘depending on the sofware tool used to perform the PEMEA. For ‘example, Function Analysis is contained inthe Form Sheet to perform the PFMEA ote«Svoqouny en 40} fa pegeue voRDUn, jana} J24by ‘231 ho, "uonsnb ey Bovansue WB 0} Heo) OM NOK Lojoes sk Uy "s6heuy Uoneun4 eu Jo yoIuD9 poreposse PLE ‘sAeuy ainonis 244 Ueemieg WewuBye moys Gey o| papnOU, ‘12 Bupoo joo pue (€'2"t) Buvequnu Jepeey uunjos aul Ways Wo4 sishreuy uoRaUNg Jo oKduIEX E-e"e a:NBLs "Heno| pUR wes OPUTA TO BUS 2008 ‘7HYEA o YOU Jo Aquressy Lonisod} eg rene pouyap ou mun eas] yuud 1ad de6 xew oy Busnoy ‘Arquiosse Busnou| Guisnoy ajod ou ow! Bure=q] 210d w uonssod jane exauyse| —9jad oqus Yes Jo Aqulossy avewus sessasd auyoeyy| 01 6uveeq paieUs ul S301 NORIETINOA sse00%d Jo 1UeWeIa Hed | wayshsqng ‘wishs jo vogoung| wey sse00%, au 40 UoRDUN “| vary osmonas syshveuy woRoung jo erdwexg Z-CE BunbIy SMES ei seomgereey tyne “Acuna TE | _—3.3.8. Collaboration between Engineering Tezms (Systems, Safety, and Components) Engineering teams within the company need to llaborate to make sure information is consistent fora projec or customer program especially when multiple PFMEA teams ar ‘simultaneously conducting the technical risk analysis. For ‘example, design information from systems, safety, andlor ‘component groups helps the PFMEA team understand the functions of the product they manufacture. This collaboration may be verbal (program meetings) or written as a summary. Basis for Failure Analysis Complete defniion of process functions (in postive words) will tead to a comprehensive Stop 4 Failure Analysis because the potential flues are ways the functions could fal (in negative words). 3.4 Process FMEA 4th Step: Failure Analysis, 3.44. Purpose “The purpose of the Process Fallure Analysis is ident fallure causes, modes, and effecis, and show their relationships to tenable risk assessment. “The main objectives ofa Procoss Fallure Analyss are: “+ Establishment of the Failure Chain “+ Potontal Failure Effects, Failure Modes, Failure Causes for ‘each process function + Identification of process falure causes using a fishbone diagram (4M) or fallure network + Collaboration between customer and supplier (Failure Etfects) + Basis forthe documentation of fllues in the FMEA form shaet and the Risk Analysis step A failure analysis 's performed for each elementstep in the process description (Structure AnalysisSiep 2 end Function Analysis/Step 3). | | | | 342 Failures Failures of a process step are deduced from preduct and process characteristics, Examples incide: + non-conformities + inconsistently or partialy executed tasks + unintentional activity > + unnecessary activity -93-3.4.3. The Failure Chain Fora specific fellure, there are three aspects to be considered: + allure Effect (FE) + Feallure Mede (FM) + allure Cause (FC) What happens? Failure Effect Focus Element Figure 3.41 Theorotical fallure chain model 3.4.4 Failure Effects Falire Etfects are related to functions of the process item (System, Subsystem, Part Element or Name of Process). Failure Effects are described in terms of what the customer might notice ‘or experience. Fallures that could impact safely or cause ‘Roncomplance to regulations should be clearly identified in the PFMEA, Customers could be: ‘+ Internal customer (next opeation/subsequent ‘operation/operation tar-gets) ‘+ Extemal customer (Next Tier LevelOEMidealer) + Legislative bodies ‘+ Product or Product end userioperator Faliure Effects are given a Severity rating according to: 1. Your Plant: the effect ofthe falure mode assuming the Gefectis detected inthe plant (what action wil the plant take, e9.,serap)2, Ship-to plant: the effect ofthe fallure mode assuming the defect is not detected before shipping to the next plant (hat action wil the next plant take, e.g, sort) 3. Enduser the effect of the process item effect (what wil the tend user notice, feel, esr, smell etc, e.g, window raises too siow) ‘The following questions should be asked to help determine the potential impact of failure effects: 1, Does the failure mode ptysically impact downstream processing or cause potential harm to equipment or operators? ‘This includes an inability to assemble or join to a mating component at any subsequent customer's facil. I s0, then identiy the manufacturing impact "Your Plant” andlor "ship-to plant In the PFMEA. If not, then go to queation 2. Examples could include: + Unable to assemble at operation x Unable to attach at customer facility + Unable to connect at customer faciliy + Cannot bore at operation x + Causes excessive tol wear at operation x + Damages equipment at operation x + Endangers operator at customer facility Note: When parts cannot be assembled there is no impact to the End User and questor 2 does not apply. 2. What s the potential impact on the End User? Independent of any controls planned or Implemented including error oF mistake-proofing, consider what happens. to the process item that leads to what the End User would nolice or experience, This information may be available within the DFMEA. If an effect is carried from the DFMEA, the description ofthe product effects in the PFMEA should be consistent with those nthe corresponding DFMEA. NOTE: In some cases, the toan conducting the analysis may not know the end user effect (e.g, catalogue pars, off- ‘he-shelf products, Tier3 components). When this information is not known, the effects should bo defined in terms ofthe par furction andlor process specification. -95-Examples could include: + Noise + High effort ‘+ Unpleasant odor + Intermitent operation + Water leak Rough idle + Unable to adjust + Difficult to contr + Poor appearance ‘+ Regulatory System Function reduced or failed + End user lack of vehicle contol + Safety effect on end user 3. What would happen i failure effect was detected prior {oreaching the end user? ‘The falure effect atthe current or receiving locations ‘also needs to be considered Identiy the manufacturing impact "Your Plant” and/or “ship-to plant” in the PEMEA, Examples could include: + Line shutdown + Stop shipment + Yard hois + 100% of product scrapped + Decreased line speed Added manpower to maintain required line rate ‘+ Rework and repair 3.45 Failure Mode {A (Precess) Failure Mode is defined as the manner in which the process could cause the product not to deliver or provide the Intended function. ‘The team should assume that the basic design of the product is corred; however, if there are design issues which result in process concems, those issues should be communicated to the ‘design team for resolution, ‘Assume thal the failure mode could occur but may not necessarily ‘occur, Failure modes should be described in technical terms, not ‘88 symptom noticeable by the customer.gS \eerication of completeness of the failure modes can be made through a review of past things-gone-wrong, reject or scrap reports, and group brainstorming. Sources for ths should also Include a comparison of similar processes and a review of ‘customer (end user and subsequent operation) claims relating to similar components. ‘There are several catenories of potential failure modes including ++ Loss of process function/operation not performed + arta function - Incomplete operation + Degradation of process function + Overachieving process function - Too much too high. + Intermittent process function - operation nat consistent ‘+ Unstable operation ‘+ Unintended process function - wrong operation + Wrong par installed + Delayed process function - operation too late ‘Typical filure modes could be, but are not limited to: + Hole too shallow, too deep, missing or off location + Dirty sutace + Surface finish too smooth ‘+ Misaligned connector pins + Connector nat fully seated ‘+ Pass a bad part, or reject a good part, bypass inspection operation + Label migsing + Barcode not readable + ECU flashed with wrong software. 3.4.6 Failure Cause A failure cause is an indication of why a faiture mode could occu ‘The consequence of a cause Is the fallure mode, Identity, to the cexient possible, every potential manufacturing or assembly cause {or each failure mode. The cause should be listed as concisely and completely as possible so that efforts (controls and actions) can be aimed at appropriate causes. “Typical fare causes may include the classic Ishikawa's 4M, bu stenotimiledto: + Man: setup worker, machine operator! ascocat, matorial ‘stocale, maintenance lechnician ete -97-+ Machine/Equipment: robot, hopper reservoir tank, Injection ‘molding machine, spiral conveyor, Inspection devices, fixtures, etc ‘+ Material (Indirect): machining ol, instalation grease, washer concentration, (ad for operation), etc. ‘+ Environdent (Milieu): ambient conditions such as hea, dust, contaminaton, lighting, nose, etc Note: In preparing the FMEA, assume that the incoming parl(s\material(s) ae correct. Exceptions ean be made by the FMEA team where historical data indicate deficiencies in incoming part qualily (One method to help ravealluncover failure causes is 1 have a facilitator that leads the team through “Thought Provoking Stimulation Questions." These questions can be broad category ‘questions, enough to stimulate the process experts thought process, while Keepin the number of questions to a manageable level. Questions can be process specific and broken down into the 4M categories. Initial ist of questions can be formed by review! the Failure Causes in previous PFMEA's Example - Assembly Process: 346A 1. From parts available within the process, can wrong part be applied? 2 Cano part be applied? 3. Can the parts be loaded incorrectly? 4, Can parts be damaged - From pickup to application? 5. Can wrong material be used”? 3.46.2 Machine 4. Can automated process be interupted? 2. Can inputted data be entered incorrectly? 3, Can machine 98 run in manual mode, bypassing automated controls? 4. Is there @ schedule to confirm prevention and detection controls? 3.4.6.3 Material (indirect) 4. Can too much/ toa lite / ne material be used? 2. Can material be applied to @ wrong location?