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What is Controlled Documentation?

  • A controlled document is a document which, if changed, effects some part of the process or product. These can be procedures , process documents, product or part drawings (prints) or other similar documents. Forms are typically controlled documents.

  • Typically there will be one or more list(s) of master documents.
  • If a controlled document is changed, a record of the change has to be made. This means there must be a History of All Changes.
  • If a document is changed, people who use it must know about the change. This means there has to be a distribution list or other effective way to let everyone who uses it know the document has changed (read Communicate the changes).
  • Every employee must know how to check to see if documentation they are using is the most current version.

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