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Total Quality Management




                    Notes          Management does not understand the FMEA, and a lot of confusion and disagreement exists as
                                   to how to fill out the FMEA form. Debate occurs when individuals attempt to develop the
                                   ratings for occurrence and detection numbers. Because accurate feedback systems don’t yet exist
                                   to base the ratings on, they’re based on inaccurate guesses. Using inaccurate ratings, the
                                   organisation calculates erroneous RPNs and identifies an RPN level at which recommended
                                   actions are needed. If the number of recommended actions required based on this level is too
                                   high, the organisation “adjusts” the ratings to bring the RPNs down below the trigger level,
                                   which reduces the number of recommended actions. Obviously, this makes the entire FMEA
                                   process meaningless.
                                   As a result, the organisation fulfills its paper requirement, but the value of the FMEA is greatly
                                   diminished. Problems still remain unsolved at a high cost to the organisation. The individuals
                                   performing the FMEAs believe they are doing them correctly because the customer or auditor is
                                   accepting them. Eventually, everyone sees the FMEA process not as a tool but as something that
                                   has to be done.

                                   Stage 2: Learning Proper FMEA Techniques

                                   Management ensures that the personnel who will perform and use the FMEA data are trained in
                                   the proper technique.





                                      Note The people who perform design FMEAs must be experts in the product and the
                                     people who perform the process FMEAs must be experts in the process.

                                   Rather than being confused by the FMEA terminology, they realize they have used the FMEA
                                   methodology before but never called it FMEA. They also learn that although they have used the
                                   methodology, they have not used it rigorously enough to achieve its full benefits.
                                   In stage two, everyone involved gains understanding of what the ratings and class column mean
                                   and how to use them to prioritize what must be worked on first. They understand that the class
                                   column is the most important factor and not the RPN. Management also realized that they don’t
                                   have systems in place that will give them data to accurately determine the failure probability
                                   occurrence ratings, detection ratings and class. Using the limited objective data they have, they
                                   know they will have to use their knowledge of the product and process to arrive at the ratings.
                                   Due to the lack of an objective basis, they know that it is a waste of time to argue for long periods
                                   about the ratings.
                                   When leaving this stage, those who have been using FMEAs believe they can be a powerful tool.
                                   Unfortunately, the people who perform FMEAs doubt whether management will provide the
                                   time and resources necessary to support their successful implementation. They also question
                                   how they will explain the new approach to their auditor or customer, who may still be at stage
                                   one in their understanding of the FMEA implementation process.

                                   Stage 3: Building a Proper FMEA

                                   The organisation begins to use FMEAs correctly on a targeted product. Early on, there is
                                   excitement that the FMEAs are finally going to be done correctly. As the implementation
                                   continues, worry starts to set in as the FMEA uncovers and documents the complexity of the
                                   product and process being analysed. Everyone knew the complexity existed but had never seen
                                   it documented. The FMEA grows from the 5 or 10 pages that used to be normal to 100 or more
                                   pages.




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