Our company uses FMEA, which only differs from the acronym for FMECA by the one word “criticality”. In an FMEA, the Failure Mode Effects Analysis addresses potential risks of the product, whether in production or distribution. There is an extensive amount of documentation that covers every part of the production process that may carry risks, and when there is a revision of any document in the database, there is always a question if this revision will require updates to the FMEA.