Few things make your heart race and your palms sweat quite like the arrival of a regulator at your organization. What's even more nerve-wracking is that it usually happens when you're least expecting it.
While you don’t necessarily know when your next audit will be or what questions a regulator will ask, there are a few things you can do to make sure you’re prepared.
To help you out, we’ve compiled a list of 5 items nearly every auditor will be looking for when they visit your organization.
Spend some time with this list to help you get comfortable with what you might be asked, what auditors really want to see, and what you can do to prove that you’re prepared.
During an audit or an investigation, regulators are examining you and your organization — not just your chemical inventory.
Can you imagine if you showed up to an interview 15 minutes late, wearing ripped jeans and sneakers, and forgot to bring a copy of your resume? A hiring manager isn't just listening to your answers; they're looking to see that you have your act together.
Similarly, a regulator isn't solely looking at your chemical labeling, or whatever the particular audit item may be. They're also looking to see that you’ve got a good handle on your chemical inventory and safety program.
What auditors (anyone, really) experience in the first few minutes of meeting you will shape their opinion of you — and once those judgments are made, they're very hard to change.
Your entire audit will go much more smoothly if you're able to start off by answering questions quickly, completely, and with accuracy and confidence.
One of the first things most auditors look for is whether your inventory is up-to-date. Are all the chemicals on your shelves accounted for? Are the amounts and locations correct?
Without an accurate inventory, your entire chemical safety program suffers. You can't accurately report on hazards because you don't actually know which chemicals are on-site. You can't train people to avoid those hazards because you don't have record that they exist. And if those chemicals have regulatory limits — which many do — there's no way to know whether those limits are exceeded.
To regulators, an out-of-date inventory is an indicator of a bigger systemic problem. If your inventory isn’t being updated regularly, it’s likely other things have fallen by the wayside as well.
To get your inventory in order, you must develop protocols and train employees to ensure that new chemicals are entered immediately, expired or used-up chemicals are removed, and chemicals are tracked when they move locations.
You also need to make sure you’re using the right tools for the job. Excel isn’t usually up to task, so using a good chemical inventory software can actively reduce the amount of work you need to do.
Around 1% of chemical incidents result in injuries to first responders, according to the Society for Disaster Medicine and Public Health. With that in mind, nearly every auditor will want to see that your inventory is not only up-to-date but also easily accessible to firefighters, police, and emergency medical personnel.
In the event of a fire, for example, firefighters need to see what hazards are present before they enter your building. Are there water reactive chemicals? Where are they located, and in what quantities? The longer it takes to access this information, the slower the response will be, resulting in more property damage and loss.
Not only can a hard-to-reach inventory delay an emergency response, it can also put first responders in danger. Failing to account for chemicals or their locations can have serious — even fatal — consequences for emergency personnel and laboratory workers.
Your chemical inventory data should be organized in a way that enables you to quickly retrieve information for first responders. That includes the ability to locate a specific lab, see major hazard categories at a glance, types of materials people are working with, and drill down on specific chemical locations and quantities.
This is another frequently-cited issue, and one you can be sure a regulator will be looking for.
Again, regulators want to see that you’ve done your due diligence to protect people from chemical hazards, so you should be able to show that safety data sheets are readily available (and if not? You should absolutely correct this even if there’s not an audit coming in).
First, make sure current SDS’s are present for all chemicals on hand. Then, double check that your system actually allows users to quickly search and find what they need in an instant.
Some organizations keep SDS’s in a binder in a central location, such as a cabinet in each lab space. Or, they keep them in folders on a computer. But the best way to accomplish this is with an electronic SDS database that is integrated with your chemical inventory. The use of an electronic SDS database is not only accepted but encouraged by chemical regulators.
Along the same lines, auditors will be concerned with ensuring that chemical containers are correctly marked with the identity of the chemical and appropriate hazard information.
Unfortunately, labels have a tendency to get wet, peel, or rub off over time. Or, researchers decant chemicals into smaller containers and never label them in the first place. In any case, you’re left scratching your head about what’s in that container — and that’s the last thing you want during an inspection.
Start by training researchers on the importance of labeling, including who is responsible for maintaining labels, how to label decanted chemicals and aliquots, and what to do if they come across an unlabeled container. Then, follow up your training with periodic checks and self-inspections to get ahead of labeling issues long before an inspector arrives.
This is a tough question, but one you can count on being asked.
Improperly stored chemicals can spill, leak, break, react with other chemicals, expose people to harm, explode or catch fire. In fact, improper storage of flammable liquids is the leading cause of industrial fires. As a result, many federal, state, and local regulations have very specific guidelines for chemical storage.
Regulators want to know that you're not only storing chemicals properly, but that you have procedures in place to ensure these guidelines are followed at all times.
For example, do you check for incompatible chemical storage on your regular safety inspections? Are there signs in storage areas reminding researchers of important storage considerations? Is chemical storage part of your researcher training? Are you properly documenting inspection findings and resolutions? All of these signal to regulators that you’re committed to proactively creating a safe research environment.
Staying prepared for a potential visit by a regulator may seem like a daunting task, but in many cases, if you’re doing a great job at managing safety, the presence of a regulator shouldn’t cause too much undue stress. If there’s still that constant fear of a regulator dropping by, it may be time to reexamine whether you need a better system for helping you manage risk and safety effectively. Your stress should be just enough to get you out of bed in the morning, but not keep you up at night.
Copyright ©2021 BioRAFT