So you’ve got an inspection coming up?
Hey Dr. Z! I got a call that my regulators are stopping by to inspect my radiation inspection program. Any tips? Thanks!
Lucky you…and good luck! Regulatory inspections are not always fun…well, to be honest, they’re usually a pain in the neck…but they’re something you’ve got to go through from time to time. The good thing about them is that, after a good inspection you’re likely to either have validation that you’ve got a good radiation safety program or you’ll have helpful suggestions on how to make your program better. My approach is to go under the assumption that my inspectors want me to have the best radiation safety program possible, which has been my own experience by and large. Here are some of my suggestions, based on my own experiences. And, for what it’s worth, I’ve been RSO for a large academic and medical license, for a city health department, a city police department (they used radioactive sources for training), and for a government laboratory – for a total of 15 years, with inspections more or less every 1-2 years. And you can see the sort of thing they’ll be looking for in the NRC inspection manual (or on a comparable state website).
One thing that’s always worked for me is always being ready for an inspection – since I can’t count on an inspector giving me notice in advance, my paperwork, calibrations, inventory records, and everything else are always up-to-date and are always ready for review. Not only that, but the most important records – radioactive materials inventory, instrument calibration, dosimetry, training, transportation and shipping – are kept in a binder at my desk. This way, when I’m inspected I can just take out that binder and let the inspectors page through it to see the records I know they’ll be most interested in. And everything else – I can get my hands on anything else within about five minutes if asked.
As far as sharing records…some RSOs go under the philosophy that anything the inspectors see is a potential violation, so they tend to make the inspectors ask for every single thing before it’s handed over. If the inspector asks for, say, dosimetry reports from the previous May then the RSO will give them the May report and make them ask for June’s. Other RSOs (me among them) will simply open a binder to the May report, handing over the entire binder so the inspector(s) can look at whatever they want.
It’s the same with escorting inspectors around your facility. First, the inspectors have a right to see anything they’d like – you can’t keep them out of a room by saying “Oh – trust me – there’s nothing of interest in there!” That being said, if there are legitimate requirements to enter an area (e.g. security clearance, special training) you’re within your rights to insist that only people who meet those requirements are permitted to enter…but when a regulator shows up who’s qualified, you’ve got to let them in. But regardless of where they go, I make it a point to accompany them (or, if I’ve got an assistant or staff, for one of them to accompany the inspectors) at all times. Mostly, if they see something that might be a violation, I want to be there when they see it – to fix it or to explain it away if possible.
Something else inspectors might want to do is to talk with some of your radiation workers and ancillary employees (these are people who don’t work with radioactivity, but who work in or near posted room). Here, too, they have the right to talk with anybody they want, and they can also insist on speaking with them privately if they’d like. Whoever they talk with, you should make sure to write down their names – that way if, say, they’re unable to answer basic questions or don’t know things they ought to, you can at least check to confirm they attended the annual training for radiation workers or ancillary workers. Inspectors might also want to talk with people in management – perhaps the VP for Environmental Health and Safety (or whoever it is that the RSO reports to) or the Chair of the Radiation Safety Committee. Here, one thing they’re looking for is to see how much they know about Radiation Safety; they’re also looking to see if these folks will even make time to talk; if they can’t be bothered to make room in their schedule then it suggests to the inspectors that your management doesn’t take radiation safety very seriously.
When they’re done your inspectors will schedule an exit interview where they’ll meet with you, your boss, your staff (if you’re lucky), and anyone else you choose to invite to the meeting. This is where the inspectors will tell you what they found, and it’s an opportunity for you to respond to their concerns. This is an opportunity to contest violations if you have iron-clad evidence they’re wrongly cited, a chance to reply (hopefully) that you’ve addressed various concerns, and a chance to hear what your inspectors are concerned about. It’s important to mention that what the inspectors discuss are only apparent violations – they’re not cited violations until you get the inspection report and letter telling you that you’ve got some violations. Which means that if you know what the inspectors are going to say (because you accompanied them on their rounds) and you’ve been able to show why what they found was not actually a violation, you can maybe get some things dropped from the official inspection report.
Finally, a few weeks to a few months after your inspection you’ll receive a letter from your regulators telling you what they found – especially violations and areas of concern. Compliments are rare – the best you can normally expect is to have no comments in an area. But whatever your inspectors say, you’re going to be required to reply to them, likely within 30 days, accepting your violations and explaining how you plan to fix them (or what you’ve already done to address them). Then – time to start work! And, as you fix things that were found to be violations, let your inspectors know (email or letter) to let them know you’re fixing the things they were concerned about.
Finally – no matter what you think about various concerns raised by your regulators, you need to take them seriously – don’t scoff or complain or roll your eyes – because your regulators are serious about them. Consider them, address their concerns (or explain why you don’t feel you need to change anything), and explain what you’ve done in the letter (or email) you send in response to your inspection report. And if there are no violations or areas of concern – have a beer or glass of wine and relax – you’ve survived until the next inspection!