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Process F.M.E.A
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Process F.M.E.A

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Training session on Process FMEA

Training session on Process FMEA

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    Process F.M.E.A Process F.M.E.A Presentation Transcript

    • Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) “Our product or process is established, it doesn’t have any failure modes.” Every product or process has modes of failure, which can arise even though your product or process is established and you are producing or performing it for years. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) “FMEA takes lot of time and resources, also it does not provide any benefit. It can be done by one person instead.” FMEA do take time and people resources as it is a team based activity. Effective FMEAs cannot be done by one person sitting alone and filling out FMEA forms. FMEA do not require complicated statistics, still it can yield significant savings for organization by reducing cost liabilities due to process or product that does not performed as required. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Current Paradigm FMEA -Taken lightly … “Selective” products / processes chosen. … Based on opinion. … All “magically” below the RPN cut-off. -Too late … Error / Mistake proofing window long gone. … Rarely validated with field results. “Paper exercise done when pushed” Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) New Paradigm FMEA Error / Mistake Process Control Maintenance Proofing Plans Plans -Taken Seriously … All critical and new products / processes. … Data driven. … Roll-up RPN values. -Early … Completed while design is still fluid. … “Living” document. “Ensures our products and processes are robust” Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) The objective of a FMEA is to look for all of the ways a process or product can fail. A product failure occurs when the product does not function as it should or when it malfunctions in some way. Failures are not limited to problems with the product. Because failures also can occur when the user makes a mistake, those types of failures should also be included in the FMEA. Anything that can be done to ensure the product works correctly, regardless of how the user operates it, will move the product closer to 100% total customer satisfaction. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Process FMEA is an effort to prevent failures (due to process) before they happen, to assess the risk associated with those failure modes, to rank the issues in terms of importance and to identify and carry out corrective actions to address the serious concerns. Process FMEAs uncover process problems related to the manufacture of the product. It is helpful when conducting a process FMEA to think in terms of the five elements of a process: People, Materials, Equipment, Methods and Environment. With these five elements in mind, ask: How can process failure affect the product, processing efficiency or safety? Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) FMEA Core Team It is helpful to have people in team who have different levels of familiarity with the product or process. Those who are most familiar with it will have valuable insights, but may overlook some of the most obvious potential problems. Those who are less familiar with the process or product will bring unbiased, objective ideas into the FMEA process. A point is often debated with FMEAs is what role the process expert plays on the FMEA team. A person with expertise in the process can bring tremendous insight to the team and can help speed the process. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Ten Steps for an Process FMEA 1) Review the process. 2) Brainstorm potential failure modes. 3) List potential effects of each failure mode. 4) Assign a Severity ranking for each effect. 5) Assign an Occurrence ranking for each failure mode. 6) Assign a Detection ranking for each failure mode and /or effect. 7) Calculate the Risk Priority Number for each effect. 8) Prioritize the failure modes for action. 9) Take action to eliminate or reduce the high-risk failure modes. 10) Calculate the resulting RPN as the failure modes are reduced or eliminated. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Ways in which a product or process can fail are called FAILURE MODES. Each failure modes has a potential effect, and some effects are more likely to occur than others. In addition, each potential effect has a relative risk associated with it. The FMEA process is a way to identify the failures, effects, and risks within a process or product, and then eliminating or reduce them. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Evaluating the Risk of Failure The relative risk of a failure and its effects is determined by three factors:  Severity – The consequence of the failure should it occur.  Occurrence – The probability or frequency of the failure occurring.  Detection – The probability of the failure being detected before the impact of the effect is realized. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Using the data and knowledge of the process or product, each potential failure mode and effect is rated in each of these three factors on a scale ranging from 1 to 10, low to high. By multiplying the ranking for the three factors (Severity x Occurrence x Detection), a risk priority number (RPN) will be determined for each potential failure mode and effect. The risk priority number (which will range from 1 to 1,000 for each failure mode) is used to rank the need for corrective actions to eliminate or reduce the potential failure modes. Once corrective action has been taken, a new RPN for the failure is determined by reevaluating the Severity, Occurrence and Detection rankings. This new RPN is called “Resulting RPN”. Improvement and corrective action must continue until the resulting RPN is at acceptable level for all potential failure modes. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) For High Severity 9/10 Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Current or Customer Process Expected Process Implementation Design Flow quality Changes and verification Requirements Diagram performance Recommended Corrective actions Process FMEA document i.e. Error proofing Process Continuous Improvement Efforts Control And RPN reduction loop Plan Operator Communication of standard Job of work to operators Instructions Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Criteria: Severity of Effect These rankings results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. Effect The final customer should always be considered first. Ranking Remarks If both occur, use the higher of two severities. Customer Effect Manufacturing / Assembly Effect Hazardous without warning Very high severity ranking when a potential failure mode affects safe Or may endanger operator (Machine or assembly) without 10 Critical characteristic vehicle operation and/or involves warning. noncompliance with government regulation without warning. Hazardous with warning Very high severity ranking when a potential failure mode affects safe Or may (Machine endanger or operator assembly) with 9 Critical characteristic vehicle operation and/or involves warning. noncompliance with government regulation with warning. Very High Vehicle / item inoperable (loss of primary function) Or 100% of product may have to be scrapped, or vehicle / item repaired 8 Major characteristic in repair shop with repair time greater than one hour. High Vehicle / item operable but at a reduced level of performance. Or product may have to be sorted and a portion (less than 100%) 7 Customer very dissatisfied. scrapped, or vehicle / item repaired in repair department with a repair time between ½ hr and an hour. Moderate Vehicle/item operable but comfort / convenience item(s) inoperable. Or a portion (less than 100%) of the product may have to be scrapped 6 Customer dissatisfied. with no sorting, or vehicle / item repaired in repair shop with a repair time of less than ½ hr. Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Criteria: Severity of Effect These rankings results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. Effect The final customer should always be considered first. Ranking Remarks If both occur, use the higher of two severities. Customer Effect Manufacturing / Assembly Effect Low Vehicle / item operable but comfort / convenience item(s) operable at a Or 100% of product may have to be reworked, or vehicle / item repaired 5 reduced level of performance. off-line but does not go to repair department. Very Low Fit and Finish / Squeak and Rattle item does not conform. Defect Or the product may have to be sorted, with no scrap, and a portion 4 noticed by most customers (greater (less than 100%) reworked. than 75%). Minor Fit and Finish / Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have to be reworked, 3 noticed by 50% of customer. with no scrap, on-line but out-of- station. Very Minor Fit and Finish / Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have to be reworked, 2 noticed by discriminating customers with no scrap, on-line but in-station. (less than 25%). None No discernible effect. Or slight inconvenience to operation or operator, or no effect. 1 Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Suggested P.F.M.E.A Occurrence Evaluation Criteria. Probability Likely Failure Rates Ranking Remarks Very High: Persistent Failures ≥ 100 per thousand pieces 10 50 per thousand pieces 9 High: Frequent Failures 20 per thousand pieces 8 10 per thousand pieces 7 Moderate: Occasional Failures 05 per thousand pieces 6 02 per thousand pieces 5 01 per thousand pieces 4 Low: Relatively Few Failures 0.5 per thousand pieces 3 0.1 per thousand pieces 2 Remote: Failure is unlikely ≤ 0.01 per thousand pieces 1 Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) Inspectio Detection Criteria n Types Suggested Range of Detection Methods Ranking A B C Almost Absolute certainty of non- Cannot detect or is not checked. Impossible detection 10 Very Control will probably not detect Control is achieved with indirect or random checks only. Remote 9 Remote Controls have poor chance of Control is achieve with visual inspection only. detection 8 Very Low Control have poor chance of Control is achieve with double inspection only. detection 7 Low Controls may detect Controls is achieved by charting methods, such as Statistical Process Control. 6 Moderate Controls may detect Control is based on variable gauging after parts have left the station, or GO/NO-GO gauging performed on 100% of the parts 5 after parts have left the station. Moderately Controls have a good chance to Error detection in subsequent operations, Or gauging High detect performed on set up and first-piece check (for set up causes 4 only). High Controls have a good chance to Error detection in-station, Or error detection in subsequent detect operations by multiple layers of acceptance: supply, select, 3 install, verify. Cannot accept discrepant part. Very High Controls almost certain to detect Error detection in-station (automatic gauging with automatic stop feature). Cannot pass discrepant part. 2 Certain Controls certain to detect Discrepant parts cannot be made because item has been error- proofed by process/product design. 1 Uniparts India Limited By: Pankaj Nalwa
    • Process Failure Mode & Effect Analysis (PFMEA) 10 Confirmed Critical Characteristic 9 S 8 e 7 Confirmed Significant v Characteristic; Action Required e 6 r 5 i 4 Annoyance t y 3 Zone 2 1 1 2 3 4 5 6 7 8 9 10 Occurrence Uniparts India Limited By: Pankaj Nalwa