An auditor requested an index of all of our equipment found out of tolerance for the past year. I didn't think I needed to create and maintain an index for equipment. I can't find the requirement. Is the auditor making an unreasonable request?
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
I absolutely agree with Energy. We have 3,000 items in our calibration database (from micrometers to electrical testers). Any auditor is welcome to ask about the history about any of them, but not ask us to go through and compile a list.
On the other hand, the calibrators notify production supervisors when a gage/instrument is found out of calibration so the supervisor can determine if the product might be out of spec as a result. The auditor might pin down the info he/she wants by going to that file.
Thanks for the feedback. I agree with your comments. We have 500 standards that calibrate 5000 instruments a year. The auditor wanted five examples of nonconforming product, but didn't want to (or us) spend a lot of time going through each file until we came up with five examples. He wanted to see if we followed our OOT and nonconforming procedures. Turned out we went through the files one at a time until we found five OOT's. (Naturally he suggested that we consider creating an index for the next audit.) Thanks again for the help.