Are we talking machines, like lathes-drill presses, etc. If so, Shop Equipment is supposed to be on scheduled maintenance. ISO 1994-Element 9 Process Control requires that you insure that equipment is maintained to support the process. The usual way is to create an "Index" (list) of equipment and the required maintenance schedule. If the auditor is asking for an Index of failure of this type of equipment, it should be non-existant if you mantain your machinery. I believe it has to with your metrology equipment. 4.11 Control of IMT&E. Each instrument should have history noting out calibration, damaged, lost, etc..If this is what the auditor is asking for, you will have to examine each piece of equipment's history to provide that info. Do I think it's an unreasonable request? Depending on the amount of equipment you have and the amount of research you will have to do to provide the info, I would tell him/her that it will take time to do it. In my opinion, there is nothing in the standard telling you that you need an Index of equipment that is reported out of tolerances. Naturally, similar or like instruments that repeatedly are out of tolerance should be cause for concern. You must be aware of any instrument that is reported out of tolerance and act on it accordingly. Repair, replace, Customer notification of product already shipped, etc..JMHO
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