Everyone, this has been very helpful! I'm so glad I was introduced to Elsmar. I mentioned this site in my Lead Auditor training class (QAI; through Exemplar Global) and the instructor had everyone stop what they were doing so that they could write down "Elsmar Cove" because according to him it is, "a fantastic resource." But back to the theme of the thread: I found some old
FMEA's (Failure Modes and Effects Analysis) for the equipment and referenced those as showing risks (lazy I know). I'm thinking this will likely not suffice and I am planning a meeting with everyone where they can tell me their risks. I'll offer that documentation as well during my audit (June 1st). Do you guys think the combination of the FMEA's and a record of risks from the staff will be sufficient?