We’ve touched on these in the discussion so far but this is a good summary of the thinking that should go into scope analysis:

  • Other products possibly affected by equipment
  • If a process document is missing a regulatory requirement, how thorough is the rest of your quality system?
  • If your audit system had a gap, are there other gaps?
  • If one software system wasn’t validated as required, are there other software systems not validated? Is your overall validation process incomplete?
  • If components received are failing, are other products impacted?
  • If a supplier is showing degraded performance on one product or service, are there other products or services being provided that are also possibly affected?

Again, without fully considering the breadth of problems, you may miss some important actions.