Good Morning Quality Professionals! We have run across a question that has become a point of contention among management and a TS consultant that is helping us move toward certification. Regarding the subject clause, what are some real-world examples that we could consider? What sort of process have you seen put in place that satisfies this requirement? What are some examples of changes that we are to be documenting with records? (ie, rev levels for prints?) Through our research (and the 'help' of the consultant), we cannot draw a neat box around this clause and determine action items to move in the right direction. Thank you all in advance!