How to Begin the FMEA

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    I am an Engineering Asst in QA in Injection Molding Industries. I am just a fresh graduates but major in quality of my course of study. Currently my superior ask me to conduct the FMEA for all the products that have produced. Anyone can advice me in how am I going to conduct the FMEA without any commiment from the company and production staff?


    Atul Bhatt

    You need to know the product design intimately well to create an FMEA; well enough to identify potential failure modes and their associated probability, detectability and impact metrics.
    If you do not possess that knowledge, you have to engage the right subject matter experts. Besides, engagement from process owners is required to ensure adequate buy-in for implementation.



    Pika – the FMEA tool focuses on issues that lead to “customer dissatisfaction”.  You will need input from a “cross-functional” team.  You may only see the issue from your perspective.  It is important to get other viewpoints (mechanical, electrical, production, engineering, sales, marketing, etc. etc.).  There is limited value if you cannot involve others or get commitment from your company.


    Raoul Smith

    Start with your company’s historical record of customer complaints.


    Mike Carnell

    I am not sure how you have arrived at the conclusion that you have no commitment from your company and production staff. You “superior” whatever that is – I am assuming it is your boss – has asked you to do it so there has to be some level of commitment somewhere.
    FMEA’s do not need to be the by-product of a love fest (this activity is handy to have in case something goes wrong and you need to share the blame or if you want to stretch it out and make a nice show right around performance appraisal time). Actually they can probably be more accurate if they are not. Remember this is Six Sigma and it is a “data driven process” so there is always the option of starting out with the data you may have. Such as:
    Process Functions – from a process map or follow some product around (pencil and paper works nicely)
    Potential Failure Modes – Defect data, law suits, customer complaints
    Potential Failure Effects – test data, engineering studies, defect insertion
    Severity – see previous two steps, ALT
    Potential Causes – test data & repair logs, field failure data
    Occurance – Process capability studies
    Current Process Controls – Process map (same pencil and paper)
    Detection – MSA
    RPN – I’ll let you figure this one out
    Actually if you take the time to put a lot of this together before you ask for some participation, you may convey to the team that you are acting as more than a facilitator and are showing respect for their time. You will also avoid someone dropping you through some cosmic bunny hole into a what if scenario that has virtually no probability of happening and kills the desire of the rest of the team.
    Actually if you have trouble getting all this together because it probably isn’t all in one spot, as an Engineering Assistant in QA you ask one of those innocent wide eyed question of the local quality czar why it isn’t collected and analyzed (the assumption is you are early in your QA career and don’t mind starting over – probably somewhere else).
    Just my opinion.
    Good luck.



    I am not sure whether Pika understands what FMEA means. Before he can do anything, he needs to get a good (solid) understanding of what this tool is all about. Once he has that, he will understand that this tool requires a thorough Process Map, maybe even a completed Cause & Effect sheets, before he can begin the FMEA chart. He needs to know what the eventual outcome of this FMEA is going to be (how he will use the FMEA tool successfully). He will understand the need to form a team which will comprise of ‘experts’ in various disciplines, he will then be able to make progress.



    Dear Pika:  I´d suggest you go to the column at the left of this screen. Click on “tools and templates”.  Click then on “FMEA/Risk Assessment”, and start enjoying yourself with the material that comes out.  Surely you’ll find there more than you asked for in your original question.
    Regards.     Sammy

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