The bioscience industry is a diverse industry composed of biotechnology, pharmaceutical, medical device and diagnostic substance companies. Bioscience companies range in size from small virtual pharmaceutical companies to large multi-national organizations, and the bioscience industry is one of the most regulated industries in the world. In addition to the Food and Drug Administration’s regulatory requirements, the bioscience industry must comply with a myriad of regulations promulgated by various environmental, health and safety regulatory agencies. For example, in the United States, these agencies include the Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency, the Nuclear Regulatory Commission, the Department of Transportation, the United States Department of Agriculture and many other state and local agencies. Despite this complex maze of regulatory requirements that must be complied with, the responsibility of ensuring compliance with these requirements may fall firmly on the shoulders of a single individual with little or no formal EHS training. In this article, the author will provide recommendations on how to effectively manage a bioscience EHS program as a single individual.
Several weeks ago, I was cleaning out the closet in my basement and discovered a binder with old environmental health and safety related articles and newspaper clippings. Some of these articles dated back to October, 1985 when Time Magazine published an article titled “The Poisoning of American.” Scanning through these articles made me reflect, as to how the environmental, health and safety profession has changed over the past 25 years.
Back in the mid-1980’s, when I started my career in the environmental, health and safety (EHS) field, the approach to managing EHS was much different than it is today. In those days, companies where largely focused on remediation and compliance. Most of the effort was on attacking the more severe and readily apparent EHS issues. Companies of any significant size were typically composed of specialized professionals – such as industrial hygiene, safety, environmental, and in some cases transportation. To make matters more complex, it was also typical to have site level personnel, district managers, regional managers, and corporate directors.
This approach to managing environmental, health safety went on for several years until the early 1990’s. At this time, the profession starting experiencing the elimination of positions, particularly at the district and regional level. EHS professionals, both at the site level and the corporate level were being asked to do more with less and take on responsibility for multiple facilities, sometimes located on opposite coasts or in different countries.
In many cases increased productivity was possible. Advances in environmental, health and safety software and compliance tracking systems made this possible. In addition, cellular phone and teleconferencing technology became more affordable, therefore, facilitating communication which previous had be done in time consuming face-to-face meetings. Regulatory requirements research that previously had to be performed by scanning through hard copy volumes of regulations can now be easily be perform from a laptop at a local coffee shop. If you’re a single-person EHS department in the life science industry, in this article I will present ten recommendations that can assist you in being effective at your job.
Not all environmental, health and safety risks are created equal. Upon joining any organization, the first priority should be to conduct a high-level risk review and prepare a complete inventory of all potential risks. I understand that they will be many in your organization that will be making demands on your time or tasking you with seemingly higher priority items for you to address, but this risk review must be performed. Otherwise, if these risks go unidentified for a period of time and not identified or addressed, you will own them. The types of risks that may be identified can range from high priority items such as uncontrolled occupational exposure to Category 4 or 5 potent compounds to minor issues, such as a missing element in a written program.
Once the risk inventory has been compiled, all risks should be ranked and prioritized. While there are many ranking schemes that can be used, in the past, I typically like to rank corrective actions according to the following order: 1) Category A: high priority items that will either cause a fatality or catastrophic incident. Improper storage of significant volumes of hazardous wastes or flammable liquids would be one example of a Category A issue. The West Pharmaceuticals Dust Explosion is another example. Category A incidents not only can cause fatalities, but also draw wide-spread media attention, cause costly production delays, and cost people their careers; 2) Category B items are issues that have legal ramifications for the organization, but are not likely to cause either fatalities, multiple severe injuries, severe environmental damage, or present a significant regulatory liability. An example of a Category B issue would be not having the proper air or wastewater permits; 3) Category C are simple compliance issues that are programmatic in nature. Examples of Category C issues would be not having all the required elements in a written plan; and 4) Category D: programmatic improvements that are not legal requirements.
If you are the sole EHS person in the organization, focus on Category A and B issues only, and delegate Category C and D issues to others in the organization or consultants. In addition, make sure that you have a solid environmental, health and safety corrective action tracking system in place to ensure that all identified issues are tracked to closure. Any issue that is identified, but left unaddressed for an extended period of time can become a regulatory or legal liability.
Once you have identified all of the issues, you should arrange a meeting with the highest-level person in the organization that you can get access. For small companies, this may be the Chief Executive Officer, for larger organizations it may be a Director or Vice President level member of management. Orchestrating this meeting must be handled delicately, and I should caution you to get approval from your manager prior to meeting with senior management. Your manager may be very sensitive about any compliance issues that may have developed while under their watch and may be concerned about being blindsided with these issues.
The purpose of this meeting is to provide an overview of the current status of the EHS efforts of the company. Information should be presented in clear, accepted business terms, and avoid the use of EHS jargon and acronyms. You should also avoid a chicken little approach that the sky is falling, and make sure that you have outlined a general plan on how you plan to resolve these issues. Be sure that you have an idea of what resources that it will require and approximate timelines. If you have, or will have, a budget, you’ll need this information for future budget planning/
You should also understand how this is connected to the overall corporate goals and strategies. Whatever strategy you come up with for resolving these issues should fit within the overall business strategy. Creating a standalone environmental, health, and safety strategy that isn’t aligned with the overall corporate business strategy will be met with strong resistance. At this point, you should mention that you would like to report back to them on a regular basis to provide them with a status update. Now, what happens if the senior management person is not interested in hearing about these issues? In this case you can either grin and bear it, or rethink what the longevity of your career at this particular company might be. In either case, you may what to think about how you framed and delivered the message.
After completion of the above meeting, it’s now time to engage the senior managers. The plan here is to get their buy-in ahead of time and determine what are their priorities and concerns. Attempting to set up one-on-one meetings at the time is probably not the best use of your time. A more favorable approach would be asking to attend a few of their general group meetings. By attending these meetings you will also get a feel for the group dynamics within each department. In the biotechnology and pharmaceutical industry, it’s usually slowing down the drug development process. When contract manufacturing organizations are concerned, it may be about handling a highly potent compound and what impact that may have on slowing down drug development. In these meetings, start identifying and developing key relationships with department personnel that will help your efforts.
Many of the issues that you will be working on will take some time to resolve and changing the culture of an organization is hard. Therefore, early in your tour of duty at a company, it’s extremely important to create a few short-term wins. These wins are something that should be meaningful to the organization, and can’t be artificially created. Examples of a short-term win could be identifying and implementing a hazardous waste reduction effort, finding some low hanging fruit for implementing a potent compound containment project, or making a signification improvement to some dreaded safety training program. Creating a few short-term wins will help build the momentum and support that will be necessary for some of the more challenging environmental, health and safety initiatives.
Both up, down, and across the organization, involve others. If you have a safety committee, make sure that it just isn’t you walking away from the meeting with all the to-do items. Push ownership for correcting these issues down in the organization. In meetings, listen carefully to even the slightest hint that there may be an environmental, health and safety concern. Sometimes these are mentioned in very subtle ways, and if left unaddressed, could be the source of a compliant to OSHA or another regulatory agency. Again, use an effective environmental, health and safety software system for tracking corrective actions to closure. Issues identified in a safety committee that go uncorrected represent a liability to your organization.
Make sure that you have a simple way to keep track of all your compliance requirements and corrective actions. While many people believe that they can develop a program from a spreadsheet, don’t waste your time. Most EHS professionals aren’t adequately trained in computer programming and there are many simple and affordable environmental, health and safety software systems that are available today.
If you’re fairly new to the environmental, health and safety field, you will be tempted to attend seminars, conferences, and professional organization chapter meetings. Stay focus, but don’t waste your time on going to every local chapter meeting of every association that you belong or attending multiple major conferences that involve expensive and time consuming travel. If your company has the funding, pick a relevant major conference and attend one. Stay close to the office until you have the program under control. The last thing you want to have happen at this point is to get labeled as a conference groupie. While it is important to network, choose wisely and stay focused on your strategic plan.
You don’t need to be an expert in this area, but at least understand the major processes associated with the development of your products. If you’re in the pharmaceutical industry, you should develop an understanding of what therapeutic or treatment areas your company is involved in and what stage that each of your products are in the overall development pipeline. A good place to start is by looking at your company’s own web site, and actually reading it. You should also pay attention to major press releases from your company. Know who your company’s chief competitors are, and how your company’s business model works (how it makes money or funds its operations).
In your career you will come up with some new, innovative, and creative ideas on how to improve your company’s environmental, health and safety performance, but there will be those steel-reinforced concrete silos in the organization that will discount your ideas. After all, if they didn’t come up with the idea, it surely must not be any good. You will also run into those individuals that want you to hire particular vendors or consultants because they are friends with them. Identify and understand who these individuals are, but don’t spend a lot of time, energy, or brain damage trying to change them. If you have a rational or regulatory reason why certain thing must be done a certain way, then stay the course. In a politically correct manner, let them know that you have considered their input.
If you happen to work for a small- to medium-size bioscience company you will eventually be involved in a merger or acquisition. The usual response to having knowledge that your company is being acquired or merged with another company is fear of job loss. Get over it. Stick to the tasks at hand and be confident. If you’re a talented EHS professional, there will be opportunities for you. It may require that you are somewhat flexible and take on additional responsibility, or travel more, but there’s no need to spend a lot of time thinking about it because you have little or no control of this issue.
New technologies such as web conferencing, hand-held data collection tools, and compliance tracking systems all have several benefits: reducing time for completing the task, eliminating errors, and improvements in analyzing issues. A few words of caution here: always remember that your main job function is manage environmental, health and safety performance, not be a computer programmer. While doing some programming may be interesting, challenging, and new, often, environmental, health and safety professionals spend an enormous amount of time and money, trying to internally develop a compliance management software solution when they could easily have selected an off the shelf solutions that would have fit their needs. To make matter worse, if the person that developed the program leaves the company, it is often difficult to know how this compliance management software system was written. If you’re the sole EHS person within your company, with limited resources, manage your time well and choose something that is rapid to implement and simple to use.
There will be those that will attempt to set you up to fail. For whatever reasons, they believe that EHS will impede the progress of their cause, cost them time or money, delay the drug development process, etc. In many cases, tactics will be deployed by withholding from you the necessary information for you to effectively perform your job. This may be important toxicology results that are necessary to evaluate or classify a potent compound, or information that is necessary to create a material safety data sheet for a potent compound. Again, stay the course and for the most part ignore them, and always communicate to management the progress you’re making. Without being arrogant, prove the value that you’re adding to the organization. This will help defuse those hand grenades.
Being a sole person EHS department in the bioscience industry is hard work. The regulatory requirements are complex and you will have many responsibilities to manage, but if you carefully identify, prioritize, and track key issues you will make progress. Always remember that you must stay focused.