A
Aaron Lupo
During an internal audit of one of our facilities I cam across something interesting. As I was doing the audit I cam across a page from one of our SOP’s which was so beautifully blown up and laminated. In short the section explained how the employees entering the room were to gown up (i.e. wash hands, put on hair bonnets, coats, etc…). So I checked the revision level that was on this page, then checked it against the actual SOP, and much to my surprise (not really) the nicely laminated document on the wall was a prior revision. When I pointed this out to the QA Manager she agreed that it needed to be removed (which it still has not been removed a month later), but then said well we can put them up as a guideline but leave the control off of it. Which to that I suggested that she not do that. First of all I explained to her that it is in a SOP, secondly it tells the employee what needs to be done, lastly I asked if you leave it up as a guideline with no control if any changes were made who would know to go change the “guideline”. Well she proceeded to argue that gown up procedures will never change they will always be the same. I politely said that gown up procedures may change they could become more or less stringent, and that if they do change that the “guideline” which would be uncontrolled would also need to be updated and revised according to our procedures. My question is am I wrong about wanting this to be controlled or can a guideline on gown up be left up?