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FMEA Rev 4 Training Material

The document discusses Failure Modes and Effects Analysis (FMEA), a structured approach to identifying and addressing potential failures in processes and products. It outlines the purpose, benefits, and various types of FMEA, including Process, Design, and System FMEA, while providing definitions for key terms and steps involved in conducting an FMEA. Additionally, it emphasizes the importance of team collaboration and continuous updates to the FMEA as processes and designs evolve.

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52 views22 pages

FMEA Rev 4 Training Material

The document discusses Failure Modes and Effects Analysis (FMEA), a structured approach to identifying and addressing potential failures in processes and products. It outlines the purpose, benefits, and various types of FMEA, including Process, Design, and System FMEA, while providing definitions for key terms and steps involved in conducting an FMEA. Additionally, it emphasizes the importance of team collaboration and continuous updates to the FMEA as processes and designs evolve.

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Dancerash Day 3: FMEA 27.03.2019 2610372017 ‘Shreeyash Consulting at E ‘ {Srreerasn Failure Modes and Effects Analysis Failure Moe =a (Defect) =>] est Real World Scenario © [ Design: A designer needs to design a new pump to minimize fuel usage waile maintaining pressure, How do we identify the effect ‘the new pump will have on the fuel usage” ‘Manufacturing: A new screw machine with improved capability is going to be added to the manufacturing floor, What effect will this have? Administrative: A shipping manager needs fo determine how anew picking process will impact the movement of trucks within the distribution center. . How would he know what factors to identify that would impact, customer deliveries? [Sieevan In this session you will learn: «The function of a FMEA ‘+ How to develop a FMEA «FMEA definitions, | «Flow to use a Process Map to identify KPIV’s \d KPOV's What is a FMEA? aa AFMEA isa disciplined procedure that allows to antitipate failures and prevent their occurrence in marjufaetuiting , by Identify ways the product or Ro cee ences Process FMEA cee | * Process FMEA: Is an analytical technique utilized as a means to assure that, to the extent possible, potential failure modes and their associated causes / mechanisms have been considered and addressed in the process stage. It basically deals with analysis of items that can go wrong based on experience and past concerns as a process is developed recess Important to Understand the Cause & Effect Relationship iim Class Exercise + Break into groups « Select a real process or use a common process such as making coffee + Each group will be required to report an example for each of the three cause and effect relationships FMEA Model Linking Failure Mode to Cause and Effect eee Fishbone Model (SM's & E) Materiats = Man Meagurement x >) Materials Man Mengurement Ns Ww Methods Machines < “Environment Goal of FMEA is to understand your process well enough to anticipate and prevent or detect the Failure Mode, a ‘ailure Modes-and Effects Analysis Function as » Helps to identity potential product/process failure modes early » Increases the likelihood that all product/process potential failure modes and their effects will be considered ~ Assists in the analysis of productiprocess design requirements and alternatives ~ Identifies potential critical characteristics and significant characteristics |» Establisties a priority for product/process improvement | actions: Documents the rationale behind productiprocess design | changes Aids in the development of process control plans What do we get from a FMEA? + List of potential failure modes « List of potential critical characteristics and potential significant characteristics « List of effects « List of causes + Documentation of current controls + Documentation and prioritization of iinprovement activities + Documentation of the history of Shreevash Purposes and Benefits of FMEA + Improves the quality, reliability, and safety of products + Increase: customer satisfaction + Reduces product development timing and cost + Documetits and tracks actions taken to reduce risk ‘System FMEA; Used to analyze systems and ‘subsystems in the early concept and design stages. Focuses on potential failure modes associated with the functions of a system caused by design. Design FMEA: Used to analyze products before they are released to production, Process FMEA: Used to analyze manufacturing and assembly processes. Types of FMEAS Srveova i it Ss) FMEA Form-Assessing Current Situation File: Fmeaform, Rates the Soverit’ ‘ofthe Effect tothe ‘Customer on a¥:0 s0 Scale xls Lists tho Effects of each Fealluro Mode aa 15 Lets the Causes for each een reese ees ieee ene santa nee a pel Soet mtr ers Strom ete ae : te 6 ‘Documents action rocommended base | Designates who is + responsible for + | etion and projected maetion data 7 ‘FMEA Definitions Failure Mode: The! manner in which a part/process can fail tc meet specification, if Usually associated with 2 defect or non-conformance. “How can the process/part fail to meet specifications?” | “Rexariless of engineering specifiertions, what would ‘a custorter (end user, subsequent operations, or service) carssider objectionable?” A failure mode is what we getisee when the process. deliverable is not correct Failure Effect: Impact on customer if Failure Mode is not prevented or corrected. Customer can be downstream or the end user. ‘Typical Fuilure Effects: for the end user) Noisy, Unstable, Rough, Wrong Price Typical Failure Effects: (for the next operation) ‘Cannot fasten, Cannot bore/tap, Does not fit, Does Hot connect 19 FMEA Definitions ‘Cause: A deficiency that results in a Failure Mode. Causes are sourcei:of variability associated with KepProcess Input, Variables. Causes are described in terms of something that ean be correeted or controlled. | ‘Typical failure causes; Improper settings — e. Software coding error Inadequate operator knowledge Inadequate or n3 lubrication Inadequate or no preventive maintenance for welding: current, time, pressure rsh ions " Currené Controls: The mechanisms that prevent or detect the Fallure Mode before it reaches your customer. ‘Typical Current Controls Statistical Process Control - SPC Inspections Monitoring ‘Comps tency Training/Certification Preventive Maintenance Sree FMEA Definitions Recommended Actions: Corrective actions to reduce loccurrence, and/or detection rankings. Directed atthe Ihighest RPN and critical severity items. Note: You san not reduce severity ranking. Your improvement actlons can only reduce the occurrence of the |defect and / or the detection of the defect. 2 FMEA Definitions Critical characteristics are those items which affect customer safety and/or could result in non- compliance to regulations and thus require controls to ensure 100% compliance. These are usually process “settings” such as temperature, time, speed, etc. Significant Characteristics are those items that require SPC and Quality planning to ensure acceptable levels of Quality (Key Process Input Variables), A Srceres Steps in the FMEA Process 11 Saeet the Process tm 7 Sart the process FMEA by 2. Develop a Process Map and ‘entiying what wil be the ienay al proces steps fuipat if exch KPOV 3. List all the Key Process Outputs requirement is not satisfied {o satistyintgraal and external (Failure Modes) ustomer requirements 8. For exch Failure Mode, identity 4. For each Process Step, list Key the Effects and Causes races ln 9, Assign Severity to ench Effect 5, Develop CSE matrix eating and an Occurrence and Product Outputs to Detestion rating t each Cause Process Inputs 10, Calelate the risk prionity |6Rantctheinputs according to number foreach potenti failure Importance meu Z . . i 11. Determine commended actions | | « to reduce high RPNs 12. Take appropriate actions 13. Re-caleulate appropriate RPNs € Coffee Exercise "&Smnplete FMEA for Coffee Making Process Zainal + For each important Process Step / Input Variable, jist ways it can go wrong | + Enter thesie into the Failure Mode column of the FMEA. | work sheet (file: FMEA form.xis) « For each Failure Mode Identify the Effect, Cause and Current Control + Assign Severity, Occurrence and Detection ratings + Calculate RPN’s for each Cause * Determine recommended actions based on RPN's. * Group Report: = Review FMEA ~ Recommend actions for process improvement 2 Who Prepares a FMEA? © The team approach to preparing FMEA‘s is recommended. ~ The responsible system, product or manufacturing! assembly expert leads the FMEA team. ~The responsible design or process expert is expected to involve representatives from all affected activitiés. Team ‘members should include Design, Manufacturing, Assembly, Quality, Reliability, Service, Purchasing, Testing; Supplier, and other subject matter experts as |__appropiiate. J Who Updates aFMEA? | "fete responsible System, Product, or Manufacturing/ Assembly expert is responsible for keeping the FMEA up to date. + Suppliers keep their own FMEA's up to date. ro Shee When is a FMEA Started? When new systems, products, and processes are being. designed, » When existing designs or processes are being changed. » When carry-over designs/processes will be used in new applications, or new environments. | » After completing a Problem Solving Study (to prevent recutrence of problem) or doing a Six Sigma Project. » Fora System FMEA, after System “unctions are defined, but before specific hardware is selected. » Fora Design FMEA, after product functions are defined, but before the design is approved and released to operations. For a Process FMEA, when preliminary drawings of the product are available, 7 When is aFMEA Updated? |e! ee + Wherever a change is being considered to a product's [ desiga, application, environment, material or its 7 ‘mantifaeturing / service process. When is 2 FMEA Completed? + A Design FMEA. is considered completed when the design is rrelease:l for product + A Prociss FMEA iv lever completed unless the process is eliminated. 2 Grater Process FMEA + Second step of a Process Review + Benefits of a Process FMEA: — Aid in the analysis of new processes — Ensute that potential process failure modes and effects will be considered . — Identify process deficiencies and provide for the development of controls to resolve the problems ~ Identify critical characteristics and significant charecteristics contributing to the development of a complete Control Plan — By risk analysis, establish priorities for process improvement activities a | Failure Modes and Effe ts Analy: Learnings of ....... + Funetion ofa FMEA + How to develop a FMEA. + FMEA definitions Severity rating ay, Severity: Is an assessment of the seriousness of the effect of the potential failure mode to the customer + List dovin potential causes of failure for these effects. Identify the occurrence for these causes of failures Occurrence mechanism is projected to occur. ‘ Put down current process controls to either prevent to the extent possible the failure mode from occurring or detect the failure mode should it occur. These controls can be voke yoke, SPC etc. of post process evaluation. Sinseyash Consng 36 ‘Suggested PFMEA OCCURANCE Evaluation Criteria robot tare ‘ety Fate ale — easly [Very igh: PenonalFolrer [> 100 periRovrand Pieces

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