{"id":8829,"date":"2020-10-01T06:01:46","date_gmt":"2020-10-01T13:01:46","guid":{"rendered":"https:\/\/www.qad.com\/blog\/?p=8829"},"modified":"2020-10-01T08:08:09","modified_gmt":"2020-10-01T15:08:09","slug":"is-the-new-fmea-handbook-a-game-changer-for-quality","status":"publish","type":"post","link":"https:\/\/www.qad.com\/blog\/2020\/10\/is-the-new-fmea-handbook-a-game-changer-for-quality","title":{"rendered":"Is the New FMEA Handbook a Game Changer for Quality?"},"content":{"rendered":"

[vc_row][vc_column][vc_single_image image=”8833″ img_size=”full”][vc_column_text]In June 2019, the US <\/span>Automotive Industry Action Group (AIAG)<\/span><\/a> and German <\/span>Verband der Automobilindustrie (VDA)<\/span><\/a> published the Failure Mode Effects Handbook in a joint effort to improve and harmonize <\/span>Failure Mode and Effects Analysis (FMEA)<\/span><\/a>. Will it be a game changer to drive real improvements in quality and effectiveness of FMEA?\u00a0<\/span><\/p>\n

Will the New 2019 Failure Mode Effects Handbook Improve FMEA?<\/span><\/h2>\n

Let\u2019s first understand the changes and objectives made compared to AIAG\u2019s prior version of the handbook – FMEA 4th Edition (published 2008).<\/span><\/p>\n

    \n
  1. 7 Steps<\/b> \u2013 These steps are the same regardless of the type of FMEA to provide a systematic approach to FMEA supporting team clarity and focus to provide results that are clear, true, realistic and complete.<\/span><\/li>\n
  2. 5Ts<\/b> \u2013 These are designed to align the cross-functional team working on the FMEA.<\/span><\/li>\n
  3. Action Priority (AP) Replacing Risk Priority Number (RPN)<\/b> \u2013 RPN has long been criticized for overemphasizing detection. AP puts emphasis on severity, then occurrence, and finally detection. It results in a High, Medium, and Low assessment of each risk where High risks should have a risk reduction action defined.<\/span><\/li>\n
  4. Monitoring and System Response (MSR) FMEA<\/b> \u2013 This is an entirely new FMEA type. It is intended to define fault mitigation during customer use to maintain a safe state or a state of regulatory compliance. This is a needed FMEA as we venture into more automated devices and transportation to ensure maximum safety during a failure or fault.<\/span><\/li>\n
  5. Foundation and Family FMEAs<\/b> \u2013 The handbook recommends the use of foundation or family FMEAs to institutionalize your knowledge, gain the efficiency of that knowledge and keep it a living document that will improve over time and which can be incorporated into existing or new products.<\/span><\/li>\n
  6. Work Elements <\/b>\u2013 In a Process Failure Mode Effects Analysis (PFMEA) the handbook details a framework to think about the types of work elements (e.g. man, machine, etc.) applicable to the PFMEA. This increases the likelihood the team will consider all reasonable potential failures or sources of variation.<\/span><\/li>\n
  7. Multiple Levels of Effect<\/b> \u2013 The handbook requires thought beyond the generic \u201ceffects\u201d of a failure mode and identifies effects on your plant, the ship to plant, and the end user of the product. By understanding the application of the product by the end user, the severity of a failure mode can be determined.<\/span><\/li>\n<\/ol>\n

    FMEA Practices that Can Put Your Business at Risk<\/span><\/h2>\n

    Let\u2019s consider some commonly observed practices that can put your business at risk:<\/span><\/p>\n

    Lack of Management Funding of FMEA<\/span><\/h3>\n

    Notice that I specifically did not call it \u201cManagement Support\u201d. To truly make your FMEA effective, it takes care and feeding, which means funding. Generally, I see a lot of instances where management does not make it a safe space for people to work on FMEA. Addressing a current <\/span>customer issue<\/span><\/a> almost always trumps this work. But what are you sacrificing? When you only pay lip service to FMEA, you don\u2019t get the intended benefits. Everyone wants dependable, high-quality and safe products, but few think about the impacts of not taking the time to do FMEA effectively.<\/span><\/p>\n

    \u00a0<\/span>Consider the impact of a quality escape caused by your organization. For a simple example, these are 26 steps to ensure you maintain your original commitment to fulfill the customer\u2019s order:<\/span>[\/vc_column_text][vc_single_image image=”8830″ img_size=”full”][vc_column_text]The red steps are the effort required by the customer. This is a huge waste of resources and some organizations have entire departments that only do this. Why do we accept this chaos? How can we prevent this? Changing our behaviors to plan for quality rather than embracing detection and fire-fighting that leads to very high cost of quality, customer satisfaction issues, margin erosion and brand risk. The new FMEA Handbook lays out a framework to help facilitate behavioral change, but it will likely not happen if management does not fund, demand and monitor adherence and outputs.<\/span><\/p>\n

    Checking the Box<\/span><\/h3>\n

    I have also seen customers do FMEA after the fact. While this may have some noble aspects (e.g. the fact that you did some <\/span>risk analysis<\/span><\/a>), the majority of cases are just efforts to \u201ccheck the box\u201d which does not lead to any of the great benefits of doing FMEA. It can lead to two fundamental problems: inspecting something that has really low risk, driving up the appraisal cost and\/or not inspecting a critical feature that can lead to recall, injury or worse.<\/span><\/p>\n

    To do FMEA efficiently and effectively, it requires time from your best resources \u2013 those that have the most experience in various functions, are highly observant, and are eager to build quality into the part.<\/span><\/p>\n

    The new FMEA handbook requires documentation of the planning, risk analysis, optimization of the high priority items, and documentation of the results of the FMEA exercise.\u00a0<\/span><\/p>\n

    Copying from a Prior Part<\/span><\/h3>\n

    Another observation is that customers often copy from a prior part\u2019s FMEA, which is not necessarily a bad thing, but is risky if that practice lacks appropriate follow through. Many customers copy a prior part\u2019s FMEA and only add failures specific to the part. What they may not incorporate are:<\/span><\/p>\n