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Let’s go back to the bakery... You have a recipe for success – it doesn’t matter what it is. Your QMS would ensure your processes are controlled so you can meet your customers’ requirements by producing your recipe consistently. If you baked cookies... You have a recipe for success – it doesn’t matter what it is. Your QMS would ensure your processes are controlled so you can meet your customers’ requirements by producing your recipe consistently:  Document Control – ensure everyone is using the same recipe.  Customer Requirements – ensure you know what they want.  Purchasing – the right ingredients matter.  Production – same size scoop, mix same way.  Environment – train people, control workplace, etc.  Calibration – ensure oven is correct so they don’t burn.  Risk – put timer on oven to prevent burning.  Audit – review orders to see if there were errors.  Etc.