ISO 9001:2015 Risk ExamplesAs part of each client engagement, we go through a process of brainstorming what risks and opportunities should be considered as part of their Quality Management System (QMS). This activity begins with determining the organization's context, which includes defining the QMS and its processes. With these processes defined, and corresponding inputs / outputs identified, we can then begin to associate "what could go wrong" with each.
A few QMS risk examples are shown below, for an imaginary company created solely for this illustration, that I'll just call "XYZ Corporation". As it happens, "XYZ" has a fairly straightforward ISO 9001:2015 Quality Management System, developed around the manufacturing of everyday widgets... Sales Risk Examples: Products/Services Overpriced Products/Services Underpriced Customer Requirements Unclear Slow Quote Didn’t quote Purchasing Risk Examples: Overpay Order Incorrectly Late Delivery Wrong Product Delivered Substandard or Defective Materials Production Risk Examples: Wrong material used Incorrect dimensions Incorrect tolerances Manufactured to obsolete drawing Contamination Inspection Risk Examples: Reject good product Accept bad product Miss inspection point Unable to perform inspection Delivery Risk Examples: Lost in shipment Damaged in shipment Delivered to incorrect location Late Delivery Stolen Summary Identifying QMS risk doesn't have to be particularly difficult, and many different companies share similar risks, although each one will likely have different views on the corresponding impact. Just take your time, give a little thought, and start out by making a simple list. Also note that some occurrences are merely beyond our control, and there is no reasonable effort that would mitigate an impact on our QMS (e.g., meteor strikes, global war, plague and the zombie apocalypse). Hope the risk examples above were helpful. Since ISO 9001 requires us to consider both risks and opportunities related to our QMS, we'll follow up with some additional examples shortly, as part of another post.
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